Company Address Certificate no. Certificate type Validity of the certificate* Reason of withdrawal Date of withdrawal*
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