Company | Address | Certificate no. | Certificate type | Validity of the certificate* | Reason of withdrawal | Date of withdrawal* |
---|---|---|---|---|---|---|
PT Dipa Global Medtek | Jl. Raya Kebayoran Lama No. 28. Jakarta 12210, Indonesia | 145059-20-12-28 | Full Quality Assurance System | 2024.05.25 | The client had not made it possible to perform the surveillance audit within the deadline | 2022.10.26 |
PT Dipa Global Medtek | Jl. Raya Kebayoran Lama No. 28. Jakarta 12210, Indonesia | 145060-20-12-28 | EC design examination certificate | 2024.05.25 | The client had not made it possible to perform the surveillance audit within the deadline | 2022.10.26 |
PT Dipa Global Medtek | Jl. Raya Kebayoran Lama No. 28. Jakarta 12210, Indonesia | 145145-21-05-17 | Full Quality Assurance System | 2024.05.25 | The client had not made it possible to perform the surveillance audit within the deadline | 2022.10.26 |
Egis Gyógyszergyár Zrt. | 1134 Budapest, Lehel u. 15. | 145195-22-04-01 | Quality Management System certificate | 2025.03.31 | The client has voluntarily requested a withdrawal | 2022.06.20 |
BVK Konsalting D.o.o. | 11000 Beograd, Kraljice Natalije 68/26, Serbia | 144880-19-04-09 | Full Quality Assurance System | 2024.04.08 | The organization did not correct a major nonconformity in time, before the suspension deadline. | 2022.05.03 |
MELBEA Innovations Kft. | 6600 Szentes, Bese László u. 8., Hungary | 145050-20-11-24 | Full Quality Assurance System | 2024.05.25 | The client has voluntarily requested a withdrawal | 2022.04.12 |
MELBEA Innovations Kft. | 6600 Szentes, Bese László u. 8., Hungary | 145051-20-11-24 | Production Quality Assurance certificate | 2024.05.25 | The client has voluntarily requested a withdrawal | 2022.04.12 |
MELBEA Innovations Kft. | 6600 Szentes, Bese László u. 8., Hungary | 145052-20-11-24 | Full Quality Assurance System | 2024.05.25 | The client has voluntarily requested a withdrawal | 2022.04.12 |
MELBEA Innovations Kft. | 6600 Szentes, Bese László u. 8., Hungary | 145053-20-11-24 | Production Quality Assurance certificate | 2024.05.25 | The client has voluntarily requested a withdrawal | 2022.04.12 |
MELBEA Innovations Kft. | 6600 Szentes, Bese László u. 8., Hungary | 144945-19-06-27 | Quality Management System certificate | 2024.05.25 | The client has voluntarily requested a withdrawal | 2022.04.12 |
Mediszintech Audiológia Kft. | 1097 Budapest, Timót u. 8. | 1097 Budapest, Timót u. 8. | Minőségirányítási rendszertanúsítvány | 2022.02.17 | The client has voluntarily requested a withdrawal | 2022.02.17 |
Denti System Kft. | 6600 Szentes,Bese László u. 8., HUNGARY | 144885-19-05-18 | Full Quality Assurance System certificate | 2024.05.17 | At the request of the organization, the certificates were separated by product type | 2021.05.25 |
Medicor Elektronika Zrt. | 1097 Budapest, Illatos út 9. HUNGARY | 144886-19-05-20 | Full Quality Assurance System certificate | 2024.05.19 | At the request of the organization, the certificates were separated by product type | 2021.05.25 |
Pronova Medical Ltd. Stl. | Karacaoglan Mah.Kemalpasa Cad. Yalcin Is Merkezi No295/F Isikkent Bornova, IZMIR, TURKIYE | 144629-16-07-22 | Full Quality Assurance System certificate | 2021.06.21 | The client has voluntarily requested a withdrawal | 2021.05.25 |
MEDITECH Kft. | 1184 Budapest, Mikszáth Kálmán utca 24. HUNGARY | 144943-19-06-22 | Full Quality Assurance System certificate | 2024.05.25 | At the request of the organization, the certificates were separated by product type | 2021.05.25 |
Wet Wipe Kft. | 3526 Miskolc, Mechatronikai park 4. HUNGARY | 145008-20-10-14 | Full Quality Assurance System certificate | 2024.05.25 | At the request of the organization, the certificates were separated by product type | 2021.05.25 |
Tov Medical Distribution S.L. | Calle San Romualdo, 26, 4th floor – 28037 Madrid, Spain | 145025-20-08-11 | Full Quality Assurance System certificate | 2024.05.25 | The client had not made it possible to perform the surveillance audit within the deadline | 2021.05.21 |
Tov Medical Distribution S.L. | Calle San Romualdo, 26, 4th floor – 28037 Madrid, Spain | 144953-19-07-18 | EC design examination certificate | 2024.05.25 | The client had not made it possible to perform the surveillance audit within the deadline | 2021.05.21 |
Tov Medical Distribution S.L. | Calle San Romualdo, 26, 4th floor – 28037 Madrid, Spain | 144952-19-07-18 | EC design examination certificate | 2024.05.25 | The client had not made it possible to perform the surveillance audit within the deadline | 2021.05.21 |
Tov Medical Distribution S.L. | Calle San Romualdo, 26, 4th floor – 28037 Madrid, Spain | 144951-19-07-18 | Full Quality Assurance System certificate | 2024.05.25 | The client had not made it possible to perform the surveillance audit within the deadline | 2021.05.21 |
Egis Gyógyszergyár Zrt. | 1106 Budapest, Keresztúri út 30-38. HUNGARY | 144702-17-05-29, 144704-17-05-29, 144790-18-09-17, 144791-18-09-17, 144806-18-12-17, 144807-18-12-17, 144809-19-02-04, 144810-19-02-04, 144946-19-07-03, 144947-19-07-03, 144968-19-10-24, 145028-20-08-19, 145029-20-08-19, 145030-20-08-19, 145031-20-08-19, 145032-20-08-19, 145033-20-08-19, 145073-21-02-09 |
Full Quality Assurance System certificate | 2022.05.28 | New certificate was issued | 2021.05.19 |
EMD Endoszkóp Kft. | H-4031 Debrecen, Bartók Béla u. 113/B. HUNGARY | 145026-20-08-11 144721-17-11-08 |
Full Quality Assurance System certificate | 2022.10.07 | The client has voluntarily requested a withdrawal | 2021.05.10 |
Bv. Holding Kft. | 1108 Budapest, Venyige utca 1-3. HUNGARY | 144641-16-08-31 | Production Quality Assurance | 2021.08.30 | New certificate was issued | 2021.04.15 |
CLS LLC | 4 Akademichesky dr, Dudareva village, Tyumen district, Tyumen region, 625501, Russia | 144800-18-11-20 | Quality Management System certificate | 2021.11.19 | The client has voluntarily requested the withdrawal | 2020.11.23 |
Gordian Surgical Ltd. | 17 Tchelet st.,Misgav Business Park, M.P. Misgav 2017400, Israel | 144637-16-08-03 | Full Quality Assurance System certificate | 2021.08.02 | The client has voluntarily requested the withdrawal | 2020.11.19 |
Gordian Surgical Ltd. | 17 Tchelet st.,Misgav Business Park, M.P. Misgav 2017400, Israel | 144638-16-08-03 | EC design examination certificate | 2021.08.02 | The client has voluntarily requested the withdrawal | 2020.11.19 |
Gordian Surgical Ltd. | 17 Tchelet st.,Misgav Business Park, M.P. Misgav 2017400, Israel | 144944-19-06-18 | Quality Management System certificate | 2022.06.17 | The client has voluntarily requested the withdrawal | 2020.11.19 |
Balton Sp. Z.o.o. | ul. Nowy Świat 7/14, 00-496 Warszawa, Poland | 144967-19-10-15 | EC design examination certificate | 2021.03.24 | A new certificate was issued | 2020.07.21 |
Balton Sp. Z.o.o. | ul. Nowy Świat 7/14, 00-496 Warszawa, Poland | 144961-19-10-15 | EC design examination certificate | 2021.03.24 | A new certificate was issued | 2020.07.21 |
Balton Sp. Z.o.o. | ul. Nowy Świat 7/14, 00-496 Warszawa, Poland | 144962-19-10-15 | EC design examination certificate | 2021.03.24 | A new certificate was issued | 2020.07.21 |
S.C. CATTUS S.R.L | Strada Gheorghe Doja, Nr. 177, cladirea C1 TG.MURES, Romania | 144956-19-07-17 | Quality Management System certificate | 2022.06.16 | The organization does not allow performing the surveillance or renewal audit in deadline/td> | 2021.01.11 |
BioScience GmbH | Walsmühler Straße 18, D-19073 Dümmer, Germany | 144600-16-01-13 | Full Quality Assurance System certificate | 2021.04.12 | A new certificate was issued | 2020.05.25 |
BioScience GmbH | Walsmühler Straße 18, D-19073 Dümmer, Germany |
144881-19-04-12 144604-16-01-13 144603-16-01-13 144602-16-01-13 144601-16-01-13 |
EC design examination certificate | 2021.04.12 | A new certificate was issued | 2020.05.25 |
BioPolymer GmbH & Co. KG | Walsmühler Straße 18, D-19073 Dümmer, Germany | 144688-17-03-22 | Full Quality Assurance System certificate | 2022.03.21 | A new certificate was issued | 2020.04.27 |
BioPolymer GmbH & Co. KG | Walsmühler Straße 18, D-19073 Dümmer, Germany | 144689-17-03-22 | EC design examination certificate | 2022.03.21 | A new certificate was issued | 2020.04.27 |
BioPolymer GmbH & Co. KG | Walsmühler Straße 18, D-19073 Dümmer, Germany | 144690-17-03-22 | EC design examination certificate | 2022.03.21 | A new certificate was issued | 2020.04.27 |
InSeal Medical Ltd. | 7 Ha’lamish St, Caesarea North Industrial Park, Caesarea 38900, Israel | 144635-16-08-03 | EC design examination certificate | 2021.08.02 | The deadline of the suspension (voluntarily requested by the client) expired | 2020.03.24 |
InSeal Medical Ltd. | 7 Ha’lamish St, Caesarea North Industrial Park, Caesarea 38900, Israel | 144634-16-08-03 | Full Quality Assurance System certificate | 2021.08.02 | The deadline of the suspension (voluntarily requested by the client) expired | 2020.03.24 |
Grünfeld Med-All International | Rostockerstrasse 9, DE-65191 Wiesbaden, Germany | 144861-19-03-05 | Production Quality Assurance certificate | 2019.12.18 | The deadline of the suspension (voluntarily requested by the client) expired | 2020.02.17 |
Dicomlab Kutatás-Fejlesztési és Szolgáltató Kft. | 6724 Szeged, Pulz u. 46/B | 144754-18-06-05 | Quality Management System certificate | 2021.06.04. | The client didn’t order the surveillance audit | 2019.10.21. |
Dicomlab Kutatás-Fejlesztési és Szolgáltató Kft. | 6724 Szeged, Pulz u. 46/B | 144753-18-06-05 | Production Quality Assurance certificate | 2023.06.04. | The client didn’t order the surveillance audit | 2019.10.21. |
VMD Gamma Kft. | 1013 Budapest, Krisztina krt. 39. | 144764-18-07-28 | Quality Management System certificate | 2021.07.27. | The client had not made it possible to perform the surveillance audit within the deadline | 2019.07.29. |
VMD Gamma Kft. | 1013 Budapest, Krisztina krt. 39. | 144765-18-07-28 | Quality Management System certificate | 2021.07.27. | The client had not made it possible to perform the surveillance audit within the deadline | 2019.07.29. |
Oxford Medical Instruments Limited | 2nd Floor Curzon House, 24 High Street, Banstead, Surrey, England, SM7 2LJ | 144744-18-05-08 | Quality Management System certificate | 2020.01.31. | The client had not made it possible to perform the surveillance audit within the deadline | 2019.06.05. |
Oxford Medical Instruments Limited | 2nd Floor Curzon House, 24 High Street, Banstead, Surrey, England, SM7 2LJ | 144745-18-05-08 | Quality Management System certificate | 2020.01.31. | The client had not made it possible to perform the surveillance audit within the deadline | 2019.06.05. |
INNO DENTAL Co., Ltd. | 812, Byucksan Digital Valley 6-cha, 219, Gasandigital 1-ro, Geumcheon-gu, Seoul 08501, Korea | 144525-14-12-03 | Full Quality Assurance System certificate | 2019.12.02. | Major nonconformity had not been corrected until the deadline | 2019.04.16. |
POLIFÉM Műanyagfeldolgozó, Ipari és Kereskedelmi Szolgáltató Kft. | 4400 Nyíregyháza, Tiszavasvári út 55. | 144631-16-07-26 | Quality Management System certificate | 2019.07.25. | The deadline of the suspension (voluntarily requested by the client) expired | 2019.04.11 |
POLIFÉM Műanyagfeldolgozó, Ipari és Kereskedelmi Szolgáltató Kft. | 4400 Nyíregyháza, Tiszavasvári út 55. | 144632-16-07-26 | Production Quality Assurance certificate | 2021.07.25. | The deadline of the suspension (voluntarily requested by the client) expired | 2019.04.11 |
Sims Health Ltd. | 2 Blacksmith Close, Oakdale, Blackwood NP12 OBG (UK) | 144588-15-10-22 | Full Quality Assurance System certificate | 2020.10.21. | Major nonconformity had not been corrected | 2019.03.06. |
Cambridge Medical Aesthetics Ltd. | Unit 43 Workspace House, 28-29 Maxwell Road, Peterborough PE2 7JE, United Kingdom | 144552-15-05-05 | Full Quality Assurance System certificate | 2020.05.04. | Due to termination of contract | 2019.03.05. |
Cambridge Medical Aesthetics Ltd. | Unit 43 Workspace House, 28-29 Maxwell Road, Peterborough PE2 7JE, United Kingdom | 144553-15-05-05 | EC design examination certificate | 2020.05.04. | Due to termination of contract | 2019.03.05. |
Cambridge Medical Aesthetics Ltd. | Unit 43 Workspace House, 28-29 Maxwell Road, Peterborough PE2 7JE, United Kingdom | 144554-15-05-05 | EC design examination certificate | 2020.05.04. | Due to termination of contract | 2019.03.05. |
Cambridge Medical Aesthetics Ltd. | Unit 43 Workspace House, 28-29 Maxwell Road, Peterborough PE2 7JE, United Kingdom | 144555-15-05-05 | EC design examination certificate | 2020.05.04. | Due to termination of contract | 2019.03.05. |
AMT Engineering Co., Ltd. | # 811-812, Byoksan Technopia, 560, Duchon-daero, Jungwon-gu, Seongnem-si, Gyeonggi-do, Korea | 144557-15-05-13 | Full Quality Assurance System certificate | 2020.05.12. | The client has voluntarily requested a withdrawal | 2019.02.06. |
CoreMedic AG | Seevorstadt 103b, CH-2502 Biel, Switzerland | 144776-18-08-23 | Quality Management System certificate | 2021.08.22 | A new certificate was issued | 2018.11.26 |
OrtoPharm Europe Kft. | 2142 Nagytarcsa, Naplás utca 24. | 144649-16-11-12 | Quality Management System certificate | 2019.03.31. | Nonconformity had not been corrected until the deadline | 2018.09.20 |
Rokána Kft. | 7624 Pécs, Buday D. u. 48. | 144599-15-12-15 | Full Quality Assurance System certificate | 2019.12.15 | Major nonconformity had not been corrected until the deadline | 2018.09.12 |
MEDIKAN Co., LTD | Human tower B1, 20-9, Jamwon-dong, Seocho-gu, Seoul, Korea | 144633-16-08-22 | Full Quality Assurance System certificate | 2021.08.21 | Major nonconformity had not been corrected until the deadline | 2018.09.11 |
Momert Zrt. | 2400 Dunaújváros Papírgyári út 12-14 | 144673-17-01-05 | Quality Management System certificate | 2019.03.31 | The client had not made it possible to perform the surveillance audit within the deadline | 2018.08.23 |
Gladius Medical Kft. | 1239 Budapest, Ócsai út 1-3. | 144626-16-07-18 | Quality Management System certificate | 2018.09.15 | The client has voluntarily requested a withdrawal | 2018.07.18 |
Gladius Medical Kft. | 1240 Budapest, Ócsai út 1-3. | 144627-16-07-18 | Quality Management System certificate | 2019.03.31 | The client has voluntarily requested a withdrawal | 2018.07.18 |
ORTHOPEDIC DESIGNS NORTH AMERICA Inc. | 5912 Breckenridge Parkway Suit F Tampa Florida USA | 144483-14-07-14 | Full Quality Assurance System certificate | 2019.07.13 | The client has voluntarily requested a withdrawal | 2018.04.27 |
ORTHOPEDIC DESIGNS NORTH AMERICA Inc. | 5912 Breckenridge Parkway Suit F Tampa Florida USA | 144680-17-03-21 | Quality Management System certificate | 2019.03.31 | The client has voluntarily requested a withdrawal | 2018.04.27 |
TUMATEC AG | Seestrasse 89., 8267 Berlingen, Switzerland | 144643-16-09-13 | Quality Management System certificate | 2019.03.31 | The client has voluntarily requested a withdrawal | 2018.04.02 |
Przedsiębiorstwo Produkcyjno-Handlowe CERKAMED Wojciech Pawłowski | ul. Kwiatkowskiego 1, 37-450 Stalowa Wola, POLAND | 144541-15-02-18 | Full Quality Assurance System certificate | 2018.10.08 | A new certificate was issued | 2018.02.18 |
SIA Henson | Matisa str. 76/78, Riga LV-1009, Latvia | 144650-16-12-15 | Quality Management System certificate | 2018.09.15. | The client has voluntarily requested a withdrawal | 2018.02.16. |
SIA Henson | Matisa str. 76/78, Riga LV-1009, Latvia | 144651-16-12-15 | Quality Management System certificate | 2019.03.31. | The client has voluntarily requested a withdrawal | 2018.02.16. |
BioPromin Ltd. | 50 Khalturina str., 61038 – Kharkiv, UKRAINE | 144623-16-07-07 | Quality Management System certificate | 2018.09.15 | The client has voluntarily requested a withdrawal | 2017.10.06 |
BioPromin Ltd. | 50 Khalturina str., 61038 – Kharkiv, UKRAINE | 144624-16-07-07 | Quality Management System certificate | 2019.07.06 | The client has voluntarily requested a withdrawal | 2017.10.06 |
ISIS VISION Co., Ltd. | #67-13, Seodongdae-Ro, 8759 Beongil, Janghowon-Eup, Icheon-Si, Gyeonggi-Do, Korea | 144515-14-10-17 | Full Quality Assurance System certificate | 2019.10.06 | Major nonconformity had not been corrected until the deadline | 2017.08.31 |
OK VISION Co., Ltd. | 83, Seungga-ro, Gimpo-si, Gyeonggi-do, KOREA | 144589-15-11-11 | Full Quality Assurance System certificate | 2020.11.10 | Major nonconformity had not been corrected until the deadline | 2017.08.31 |
VMD 95 Kereskedelmi és Szolgáltató Kft. | 1163 Budapest, Színjátszó u. 19. | 144595-15-12-15 | Full Quality Assurance System certificate | 2018.08.29 | Major nonconformity had not been corrected until the deadline | 2017.08.08 |
Coats Magyarország Kft. | 1044 Budapest, Váci út 91. | 144580-15-09-17 | Production Quality Assurance certificate | 2020.09.16 | The client has voluntarily requested a withdrawal | 2017.07.31 |
Wirtum BioKibernetikai Fejlesztő Bt. | 1172 Budapest, Jászapáti utca 3. | 144531-15-01-12 | Quality Management System certificate | 2018.01.11 | The client has voluntarily requested a withdrawal | 2017.02.07 |
Axetis AG | Usteristrasse 9, CH-8001 Zürich. | 144617-16-05-02 | Quality Management System certificate | 2019.05.01 | The client has voluntarily requested a withdrawal | 2017.01.12 |
Dental Easy Implant Kft. | 5500 Békéscsaba, Andrássy u. 37-43. III. em. | 1444425-13-05-02 | Full Quality Assurance System certificate | 2018.05.01 | The client has voluntarily requested a withdrawal | 2016.11.21 |
Audiosystem Kft. | 2310 Szigetszentmiklós, Kinizsi u. 104.. | 144532-15-01-17 | Quality Management System certificate | 2018.01.16 | The client has voluntarily requested a withdrawal | 2016.07.13 |
Ohsung Electronics Co., Ltd. Gumi Factory | 181 Gong Dan-Dong, Gumi, Gyeong Buk, Korea | 144479-14-05-28 | Full Quality Assurance System certificate | 2019.05.27 | The client has voluntarily requested a withdrawal | 2016.02.02 |
Ohsung Electronics Co., Ltd. Gumi Factory | 181 Gong Dan-Dong, Gumi, Gyeong Buk, Korea | 144480-14-05-28 | Quality Management System certificate | 2017.05.27 | The client has voluntarily requested a withdrawal | 2016.02.02 |
RASON Co., LTD | Sejung Technovally 1206, 134, Gongdan-ro, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, Korea | 144520-14-11-10 | Full Quality Assurance System certificate | 2019.11.09 | The client has voluntarily requested a withdrawal | 2016.02.02 |
D’Avanti KKT. | 1094 Budapest, Páva u. 26. II. em. 5. | 144574-15-08-01 | Quality Management System certificate | 2018.07.31 | The client has voluntarily requested a withdrawal | 2016.02.01 |
D’Avanti KKT. | 1094 Budapest, Páva u. 26. II. em. 5. | 144575-15-08-01 | Production Quality Assurance certificate | 2020.07.31 | The client has voluntarily requested a withdrawal | 2016.02.01 |
VANGUARD Orthopedic Solutions LLC | 5912 Breckenridge Parkway Suite F Tampa Florida USA | 144507-14-08-19 | Full Quality Assurance System certificate | 2016.11.10 | The client has voluntarily requested a withdrawal | 2015.07.30 |
CVBIO Co. Ltd. | #806. Woolim Lionsvally 1st. 311-3, Sangdaewon(1)-dong, Jungwon-gu, Seongnam-si, Kyeonggi-do, 462-806 Korea | 144450-13-10-21 | Full Quality Assurance System certificate | 2018.10.20 | Major nonconformity had not been corrected until the deadline | 2014.08.12 |
CHOKHANI PHARMA | 132 dr. A.B.Road, 306 Kakad Chambers, Mumbai – 400018, Maharashtra, INDIA | 144448-13-10-03 | Full Quality Assurance System certificate | 2018.05.01 | The client had not made it possible to perform the surveillance audit within the deadline | 2014.06.25 |
Medi-Life Industries | 49/4, Mathura Road, Faridabad – 121 102 Hariana, INDIA | 144445-13-07-26 | Full Quality Assurance System certificate | 2017.06.21 | The client had not made it possible to perform the surveillance audit within the deadline | 2014.06.25 |
Medi-Life Industries | 49/4, Mathura Road, Faridabad – 121 102 Hariana, INDIA | 144444-13-07-26 | Full Quality Assurance System certificate | 2015.02.07 | The client had not made it possible to perform the surveillance audit within the deadline | 2014.06.25 |
QUIP Inc. | Office No : 6, Damji Meghji Building, 21 Keshavji Naik Road, Bhat Bazar, Mumbai – 400 009, INDIA | 1444427-13-05-06 | Full Quality Assurance System certificate | 2015.08.09 | The client had not made it possible to perform the surveillance audit within the deadline | 2014.06.25 |
Mediszintech Orvostechnikai Kft. | 1097 Budapest, Timót u. 8. | 144404-12-02-13 | Quality Management System certificate | 2015.02.12 | The client had not made it possible to perform the surveillance audit within the deadline | 2014.06.20 |
Mediszintech Orvostechnikai Kft. | 1097 Budapest, Timót u. 8. | 144405-12-02-13 | Quality Management System certificate | 2015.02.12 | The client had not made it possible to perform the surveillance audit within the deadline | 2014.06.20 |
Titanium Biotech Kft. | 2310 Szigetszentmiklós, Kazinczy utca 4. | 144406-12-02-20 | Quality Management System certificate | 2015.02.19 | The client had not made it possible to perform the surveillance audit within the deadline | 2013.07.15 |
PolarTherapy Kft. | 1074 Budapest, Hutyra Ferenc u. 11-15. | 144395-11-08-12 | Quality Management System certificate | 2014.08.11 | The client has voluntarily requested a withdrawal | 2012.06.27 |
PolarTherapy Kft. | 1074 Budapest, Hutyra Ferenc u. 11-15. | 144396-11-08-12 | Quality Management System certificate | 2014.08.11 | The client has voluntarily requested a withdrawal | 2012.06.27 |
*Form of dates within the table: yyyy/mm/dd