| Company | Address | Certificate no. | Certificate type | Date of suspension* | Reason of the suspension | Deadline of suspension* | Consequence of the suspension |
|---|---|---|---|---|---|---|---|
| UniCare GmbH | Mittelstraße 7, 12529 Schönefeld, Germany | 144979-20-03-23 | Quality Management System certificate | 2022.10.12 | The client has voluntarily requested a suspension | 2023.04.11 | |
| Juves Sarl | 52 Boulevard Sébastopol, 75003, Paris, France | 144948-19-07-11 | Full Quality Assurance System certificate | 2022.05.20 | Major nonconformity had not been corrected until the deadline | 2022.12.19 | |
| Juves Sarl | 52 Boulevard Sébastopol, 75003, Paris, France | 144949-19-07-11 | EC design examination certificate | 2022.05.20 | Major nonconformity had not been corrected until the deadline | 2022.12.19 | |
| Juves Sarl | 52 Boulevard Sébastopol, 75003, Paris, France | 144950-19-07-11 | EC design examination certificate | 2022.05.20 | Major nonconformity had not been corrected until the deadline | 2022.12.19 | |
| Juves Sarl | 52 Boulevard Sébastopol, 75003, Paris, France | 145111-21-05-12 | EC design examination certificate | 2022.05.20 | Major nonconformity had not been corrected until the deadline | 2022.12.19 | |
| PT Dipa Global Medtek | Jl. Raya Kebayoran Lama No. 28. Jakarta 12210, Indonesia | 145059-20-12-23 | Full Quality Assurance System certificate | 2022.04.26 | The client had not made it possible to perform the surveillance audit within the deadline | 2022.10.25 | withdrawn |
| PT Dipa Global Medtek | Jl. Raya Kebayoran Lama No. 28. Jakarta 12210, Indonesia | 145060-20-12-23 | EC design examination certificate | 2022.04.26 | The client had not made it possible to perform the surveillance audit within the deadline | 2022.10.25 | withdrawn |
| PT Dipa Global Medtek | Jl. Raya Kebayoran Lama No. 28. Jakarta 12210, Indonesia | 145145-21-05-17 | Full Quality Assurance System certificate | 2022.04.26 | The client had not made it possible to perform the surveillance audit within the deadline | 2022.10.25 | withdrawn |
| BVK Konsalting D.o.o. | 11000 Beograd, Kraljice Natalije 68/26, Serbia | 144880-19-04-09 | Full Quality Assurance System certificate | 2021.11.03 | Major nonconformity hindering the operation of the certified quality management system | 2022.05.02 | withdrawn |
| MEDITECH Egészségügyi Szolgáltató, Műszerfejlesztő és Kereskedelmi KFT. | 1184 Budapest, Mikszáth Kálmán utca 24. | 145135-21-05-25 | Full Quality Assurance System certificate | 2021.11.03 | Major nonconformity hindering the operation of the certified quality management system | 2022.05.02 | reinstalled |
| Wet-Wipe Kft. | 3526 Miskolc, Mechatronikai park 4. | 145151-21-05-25 | Full Quality Assurance System certificate | 2021.06.16 | Major nonconformity hindering the operation of the certified quality management system | 2021.12.16 | reinstalled |
| Wet-Wipe Kft. | 3526 Miskolc, Mechatronikai park 4. | 145152-21-05-25 | Full Quality Assurance System certificate | 2021.06.16 | Major nonconformity hindering the operation of the certified quality management system | 2021.12.16 | reinstalled |
| Wet-Wipe Kft. | 3526 Miskolc, Mechatronikai park 4. | 145153-21-05-25 | Full Quality Assurance System certificate | 2021.06.16 | Major nonconformity hindering the operation of the certified quality management system | 2021.12.16 | reinstalled |
| Wet-Wipe Kft. | 3526 Miskolc, Mechatronikai park 4. | 145154-21-05-25 | Full Quality Assurance System certificate | 2021.06.16 | Major nonconformity hindering the operation of the certified quality management system | 2021.12.16 | reinstalled |
| Egis Gyógyszergyár Zrt. | 1106 Budapest, Keresztúri út 30-38. | 144968-19-10-24 | Full Quality Assurance System certificate | 2021.02.09 | Validation of Hydrofemin Plus 75g on the new site is not verified in the Technical File | 2021.05.20 | withdrawn (for further information see: withdrawn certificates) |
| TOV Medical | Calle San Romualdo, 26, 4th floor – 28037 Madrid, Spain | 144951-19-07-18 | Full Quality Assurance System certificate | 2021.02.09 | The organization does not allow performing the surveillance or renewal audit in deadline | 2021.05.20 | withdrawn (for further information see: withdrawn certificates) |
| TOV Medical | Calle San Romualdo, 26, 4th floor – 28037 Madrid, Spain | 144952-19-07-18 | EC design examination certificate | 2021.02.09 | The organization does not allow performing the surveillance or renewal audit in deadline | 2021.05.20 | withdrawn (for further information see: withdrawn certificates) |
| TOV Medical | Calle San Romualdo, 26, 4th floor – 28037 Madrid, Spain | 144953-19-07-18 | EC design examination certificate | 2021.02.09 | The organization does not allow performing the surveillance or renewal audit in deadline | 2021.05.20 | withdrawn (for further information see: withdrawn certificates) |
| EMD Endoszkóp Kft. | H-4031 Debrecen, Bartók Béla u. 113/B. | 145025-20-08-11 | Full Quality Assurance System certificate | 2020.08.11 | Major nonconformity affecting the Quality Management System | 2021.02.11 | reinstalled |
| S.C. CATTUS S.R.L. | Str. Gheorghe Doja, Nr. 177, building C1, 540210 Târgu Mureș, România |
144956-19-07-17 | Quality Management System certificate | 2020.07.20 | The organization does not allow performing the surveillance or renewal audit in deadline | 2021.01.10. | withdrawn (for further information see: withdrawn certificates) |
| Gordian Surgical Ltd. | 17 Tchelet St., Misgav Business Park, M.P. Misgav 2017400, Israel | 144638-16-08-03 | EC design examination certificate | 2020.07.16 | Major nonconformity hindering the operation of the certified quality management system | 2021.01.16 | |
| Gordian Surgical Ltd. | 17 Tchelet St., Misgav Business Park, M.P. Misgav 2017400, Israel | 144637-16-08-03 | Full Quality Assurance System certificate | 2020.07.16 | Major nonconformity hindering the operation of the certified quality management system | 2021.01.16 | |
| Gordian Surgical Ltd. | 17 Tchelet St., Misgav Business Park, M.P. Misgav 2017400, Israel | 144944-19-06-18 | Quality Management System certificate | 2020.07.16 | Major nonconformity hindering the operation of the certified quality management system | 2021.01.16 | |
| LASRAM Enginering Kft | 1044 Budapest, Ezred utca 2. B2/2 | 144736-18-04-06 | Full Quality Assurance System certificate | 2020.03.11. | Major nonconformity had not been corrected until the deadline | 2020.09.11 | |
| LASRAM Enginering Kft | 1044 Budapest, Ezred utca 2. B2/2 | 144738-18-04-06 | Quality Management System certificate | 2020.03.11. | Major nonconformity had not been corrected until the deadline | 2020.09.11 | reinstalled |
| LASRAM Enginering Kft | 1044 Budapest, Ezred utca 2. B2/2 | 144737-18-04-06 | Quality Management System certificate | 2020.03.11. | Major nonconformity had not been corrected until the deadline | 2020.09.11 | reinstalled |
| Grünfeld Med-All International | Rostockerstrasse 9, DE-65191 Wiesbaden, Germany | 144861-19-03-05 | Production Quality Assurance certificate | 2019.12.18 | The client has voluntarily requested the suspension | 2020.02.15 | withdrawn (for further information see: withdrawn certificates) |
| InSeal Medical Ltd. | 7 Ha’lamish St, Caesarea North Industrial Park, Caesarea 38900, Israel | 144634-16-08-03 | Full Quality Assurance System certificate | 2019.09.25 | The client has voluntarily requested the suspension | 2020.03.24 | withdrawn (for further information see: withdrawn certificates) |
| InSeal Medical Ltd. | 7 Ha’lamish St, Caesarea North Industrial Park, Caesarea 38900, Israel | 144635-16-08-03 | EC design examination certificate | 2019.09.25 | The client has voluntarily requested the suspension | 2020.03.24 | withdrawn (for further information see: withdrawn certificates) |
| WON TECH Co., Ltd. | 64 Techno 8-ro, Yuseung-gu, Daejeon, Korea | 144484-14-03-28 | Full Quality Assurance System certificate | 2018.11.27 | Due to a notification of a Competent Authority | 2019.03.26 | new certificate was issued |
| 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 | 2018.10.24 | Major nonconformity had not been corrected until the deadline | 2019.04.23 | withdrawn (for further information see: withdrawn certificates) |
| 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 | 2018.10.24 | Major nonconformity had not been corrected until the deadline | 2019.04.23 | withdrawn (for further information see: withdrawn certificates) |
| 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 | 2018.10.24 | Major nonconformity had not been corrected until the deadline | 2019.04.23 | withdrawn (for further information see: withdrawn certificates) |
| 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 | 2018.10.24 | Major nonconformity had not been corrected until the deadline | 2019.04.23 | withdrawn (for further information see: withdrawn certificates) |
| 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 | 2018.10.16 | Major nonconformity had not been corrected until the deadline | 2019.04.15 | withdrawn |
| POLIFÉM Műanyagfeldolgozó, Ipari és Kereskedelmi Szolgáltató Kft. | 4400 Nyíregyháza, Tiszavasvári út 55. | 144631-16-07-26 | Quality Management System certificate | 2018.10.11 | The client has voluntarily requested the suspension | 2019.04.10 | withdrawn |
| POLIFÉM Műanyagfeldolgozó, Ipari és Kereskedelmi Szolgáltató Kft. | 4401 Nyíregyháza, Tiszavasvári út 55. | 144632-16-07-26 | Production Quality Assurance certificate | 2018.10.11 | The client has voluntarily requested the suspension | 2019.04.10 | withdrawn |
| HIP KNEE MEDIKAL | 10016 Sokak, No:20 AOSB Cigli, Izmir, Turkey | 144546-15-04-17 | Full Quality Assurance System certificate | 2018.09.03 | Major nonconformity had not been corrected until the deadline | 2019.03.02 | reinstalled |
| HIP KNEE MEDIKAL | 10017 Sokak, No:20 AOSB Cigli, Izmir, Turkey | 144547-15-04-17 | EC design examination certificate | 2018.09.03 | Major nonconformity had not been corrected until the deadline | 2019.03.02 | reinstalled |
| HIP KNEE MEDIKAL | 10018 Sokak, No:20 AOSB Cigli, Izmir, Turkey | 144548-15-04-17 | EC design examination certificate | 2018.09.03 | Major nonconformity had not been corrected until the deadline | 2019.03.02 | reinstalled |
| Rokána Kft. | 7624 Pécs, Buday D. u. 48. | 144599-15-12-15 | Full Quality Assurance System certificate | 2018.03.12 | Major nonconformity had not been corrected until the deadline | 2018.09.12 | withdrawn |
| Momert Zrt. | 2400 Dunaújváros Papírgyári út 12-14 | 144673-17-01-05 | Quality Management System certificate | 2018.02.23 | The client had not made it possible to perform the surveillance audit within the deadline | 2018.08.23 | withdrawn |
| Dental Easy Implant Kft. | 5500 Békéscsaba, Andrássy u. 37-43. III. em. | 1444425-13-05-02 | Full Quality Assurance System certificate | 2016.05.17 | The client has voluntarily requested the suspension | 2016.11.16 | withdrawn |
| BioScience GmbH | Walsmühler Straße 18, D-19073 Dümmer, Germany | 144600-16-01-13 | Full Quality Assurance System certificate | 2016.02.12 | Due to a notification of a Competent Authority | 2016.08.12 | reinstalled |
| BioScience GmbH | Walsmühler Straße 18, D-19073 Dümmer, Germany | 144601-16-01-13 | EC design examination certificate | 2016.02.12 | Due to a notification of a Competent Authority | 2016.08.12 | reinstalled |
| BioScience GmbH | Walsmühler Straße 18, D-19073 Dümmer, Germany | 144602-16-01-13 | EC design examination certificate | 2016.02.12 | Due to a notification of a Competent Authority | 2016.08.12 | reinstalled |
| BioScience GmbH | Walsmühler Straße 18, D-19073 Dümmer, Germany | 144603-16-01-13 | EC design examination certificate | 2016.02.12 | Due to a notification of a Competent Authority | 2016.08.12 | reinstalled |
| BioScience GmbH | Walsmühler Straße 18, D-19073 Dümmer, Germany | 144604-16-01-13 | EC design examination certificate | 2016.02.12 | Due to a notification of a Competent Authority | 2016.08.12 | reinstalled |
| Mediszintech Orvostechnikai Kft. | 1097 Budapest, Timót u. 8. | 144404-12-02-13 | Quality Management System certificate | 2013.12.08 | The client had not made it possible to perform the surveillance audit within the deadline | 2014.06.20 | withdrawn |
| Mediszintech Orvostechnikai Kft. | 1097 Budapest, Timót u. 8. | 144405-12-02-13 | Quality Management System certificate | 2013.12.08 | The client had not made it possible to perform the surveillance audit within the deadline | 2014.06.20 | withdrawn |
| Titanium Biotech Kft. | 2310 Szigetszentmiklós, Kazinczy utca 4. | 144406-12-02-20 | Quality Management System certificate | 2013.01.14 | The client had not made it possible to perform the surveillance audit within the deadline | 2013.07.14 | withdrawn |
*Form of dates within the table: yyyy/mm/dd