23.01.2026
To the attention of all importers, distributors and users of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market ‘Sterile Non-active Medical Devices’ manufactured by Guangzhou AMK Medical Equipment Co., Ltd., China for which they have come into possession of the falsified copy of the EC certificate of conformity no. G2 001281 0001 Rev. 02, which would have been issued by Notified Body TÜV SÜD Product Service GmbH (0123) on 2021-04-29 and valid until 2025-05-26 for this manufacturer.
The valid CE Certificate of Conformity with No. G2 001281 0001 Rev. 02 was issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123) on 2020-04-29, valid until 2024-05-26 for Sterile Non-active Medical Devices and belongs to manufacturer Guangzhou AMK Medical Equipment Co., Ltd., China.
If you have come into possession of such medical devices or are aware of distributors who sell Sterile Non-active Medical Devices on the Romanian territory based on a falsified copy of certificate no. G2 001281 0001 Rev.02, do not use them and notify the National Agency for Medicines and Medical Devices of Romania – the Market Surveillance Service, using the contact details posted on the NAMMDR website.
For your own verification, we recommend that interested parties consult the information posted on the website of Notified Body TÜV SÜD Product Service GmbH, Germany (0123), by accessing the links below:
Database of issued certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank
Database of falsified certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank/tuev-sued-pruefzeichen/liste-gefaelschter-zertifikate

19.01.2026
To the attention of all importers, distributors and users of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market medical devices type ‘Infusion Set, Lap Sponges, Sterile Medication Set, Gauze Swabs without X-ray Thread, Gauze Swabs with X-ray, Non-woven Swabs with X-ray Thread’, manufactured by Bluemed Healthcare Co., Ltd., China, for which they came into possession of the falsified copy of CE certificate of conformity no. G2 17 07 99160 003, which was allegedly issued by Notified Body TÜV SÜD Product Service GmbH (0123) on 2017-11-17 and valid until 2024-11-16 for this manufacturer.
The valid CE Certificate of Conformity with No. G2 17 07 99160 003 was issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123) on 2017-11-17, valid until 2022-11-16 for ‘Infusion Set, Lap Sponges, Gauze Swabs without X-ray Thread, Gauze Swabs with X-ray, Sterile Non-woven Swabs with X-ray Thread’ and belongs to manufacturer Bluemed Healthcare Co., Ltd., China.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory ‘Infusion Set, Lap Sponges, Sterile Medication Set, Gauze Swabs without X-ray Thread, Gauze Swabs with X-ray, Non-woven Swabs with X-ray Thread’ based on the falsified copy of certificate no. G2 17 07 99160 003, do not use them and notify the National Agency for Medicines and Medical Devices of Romania – the Market Surveillance Service using the contact details posted on the NAMMDR website.
Database of issued certificates: For your own verification, we recommend that interested parties consult the information posted on the website of Notified Body TÜV SÜD Product Service GmbH, Germany (0123), by accessing the links below:
Database of issued certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank
Database of falsified certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank/tuev-sued-pruefzeichen/liste-gefaelschter-zertifikate

19.06.2025
To the attention of all importers, distributors and users of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market medical devices of type ‘Infusion Sets for Single Use (with Needle), Sterile Hypodermic Syringes for Single Use (with Needle), Disposable Sterile Hypodermic Needles, Scalp vein Sets, Sterile Insulin Syringes for Single Use, Disposable Transfusion Set (with Needle), Urine Collection Bags’ accompanied by the falsified CE certificate no. Q6 073425 0011 Rev. 02, which would have been issued by Notified Body TÜV SÜD Product Service GmbH (0123) on 2022-09-06 and valid until 2025-09-05.
The valid certificate with the same identification data, namely number, product categories, issue and expiry date belongs to manufacturer Jiangsu Zhengkang Medical Apparatus Co., Ltd., China and was issued by Certifying Body TÜV SÜD Product Service GmbH, Germany in accordance with the requirements of standard EN ISO 13485:2016 – Medical devices — Quality management systems — Requirements for regulatory purposes for ‘Production and Distribution of Infusion Sets for Single Use (with Needle), Sterile Hypodermic Syringes for Single Use (with Needle), Disposable Sterile Hypodermic Needles, Scalp vein Sets, Sterile Insulin Syringes for Single Use, Disposable Transfusion Set (with Needle), Urine Collection Bags’.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory ‘Infusion Sets for Single Use (with Needle), Sterile Hypodermic Syringes for Single Use (with Needle), Disposable Sterile Hypodermic Needles, Scalp vein Sets, Sterile Insulin Syringes for Single Use, Disposable Transfusion Set (with Needle), Urine Collection Bags’ based on the falsified copy of certificate no. Q6 073425 0011 Rev. 02, do not use them and notify the National Agency for Medicines and Medical Devices of Romania – the Market Surveillance Service using the contact details posted on the NAMMDR website.
For your own verification, we recommend that interested parties consult the information posted on the website of Notified Body, TÜV SÜD Product Service GmbH, Germany (0123), by accessing the links below:
Database of issued certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank
Database of falsified certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank/tuev-sued-pruefzeichen/liste-gefaelschter-zertifikate

18.06.2025
To the attention of all importers, distributors and users of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market medical devices of type ‘Disposable Airways, Urine Bag, Vaginal Speculum, Sterile Wound Plaster’ accompanied by a falsified copy of CE certificate of conformity no. G2S 104356 0003 Rev.01, which would have been issued by Notified Body TÜV SÜD Product Service GmbH (0123) on 2023-02-09 and valid until 2025-12-29.
The valid CE certificate of conformity with no. G2S 104356 0003 Rev.01 was issued by Notified Body TÜV SÜD Product Service GmbH (0123) on 2021-05-03, valid until 2024-05-26, for ‘Disposable Airways, Urine Bag, Vaginal Speculum, Sterile Wound Plaster’ and belongs to manufacturer Ningbo Great Mountain Medical Instruments Co., Ltd., China.
If you have come into possession of such medical devices or are aware of distributors who sell ‘Disposable Airways, Urine Bag, Vaginal Speculum, Sterile Wound Plaster’ on the Romanian territory based on the falsified copy of the EC certificate of conformity no. G2S 104356 0003 Rev.01, do not use them and notify the National Agency for Medicines and Medical Devices of Romania – the Market Surveillance Service using the contact details posted on the NAMMDR website.
For your own verification, we recommend that interested parties consult the information posted on the website of Notified Body TÜV SÜD Product Service GmbH, Germany (0123), by accessing the links below:
Database of issued certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank
Database of falsified certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank/tuev-sued-pruefzeichen/liste-gefaelschter-zertifikate

18.06.2025
To the attention of all importers, distributors and users of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market medical devices of type ‘Ligation Clips for Single Use’ accompanied by a falsified copy of CE certificate of conformity no. HD 60104799 0001, which would have been issued by Notified Body TÜV Rheinland LGA Products GmbH, Germany (0197) on 2023-02-02 and valid until 2028-01-01.
The valid CE Certificate of Conformity with No. HD 60104799 0001, issued by Notified Body TÜV Rheinland LGA Products GmbH, Germany (0197) on 2015-11-02, valid until 2018-06-03, for the same product category, belonged to manufacturer Tonglu Zhouji Medical Instrument Co., Ltd., China.
If you have come into possession of such medical devices or are aware of distributors who sell ‘Ligation Clips for Single Use’ on the Romanian territory based on a falsified copy of the EC certificate of conformity no. HD 60104799 0001, do not use them and notify the National Agency for Medicines and Medical Devices of Romania – the Market Surveillance Service using the contact details posted on the NAMMDR website.
For your own verification, we recommend that interested parties consult the information posted on the website of Notified Body TÜV Rheinland LGA Products GmbH, Germany (0197), by accessing the links below:
– database with valid certificates: https://www.certipedia.com/?locale=en
– database with falsified certificates: https://www.tuv.com/world/en/warning-list/

18.06.2025
To the attention of all importers, distributors and users of medical devices
18.06.2025
To the attention of all importers, distributors and users of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market medical devices of type ‘Pulse Oximeter, SPO2 Sensor, Patient Monitor’ accompanied by a falsified copy of CE certificate of conformity no. G1 087056 0005 Rev. 02, which would have been issued by Notified Body TÜV SÜD Product Service GmbH (0123) on 2024-05-15 and valid until 2028-12-31.
The valid CE certificate of conformity with no. G1 087056 0005 Rev. 02 was issued by Notified Body TÜV SÜD Product Service GmbH (0123) on 2019-05-16, valid until 2024-05-15, for ‘SPO2 Monitor, Pulse Oximeter, Spo2 Sensor, Patient Monitor’ and belongs to manufacturer Shanghai Berry Electronic Tech Co., Ltd., China.
If you have come into possession of such medical devices or are aware of distributors who sell ‘Pulse Oximeter, SPO2 Sensor, Patient Monitor’ on the Romanian territory based on the falsified copy of CE certificate of conformity no. G1 087056 0005 Rev. 02, do not use them and notify the National Agency for Medicines and Medical Devices of Romania – the Market Surveillance Service using the contact details posted on the NAMMDR website.
For your own verification, we recommend that interested parties consult the information posted on the website of Notified Body TÜV SÜD Product Service GmbH, Germany (0123), by accessing the links below:
Database of issued certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank
Database of falsified certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank/tuev-sued-pruefzeichen/liste-gefaelschter-zertifikate

17.06.2025
To the attention of all importers, distributors and users of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market medical devices of type ‘Clinical Electronic Thermometers – Infrared Ear/Forehead Thermometers – Infrared Ear Thermometers – Infrared Forehead Thermometers – Nerve and Muscle Stimulators – Electrical Acupuncture Stimulators – Transcutaneous Electrical Nerve Stimulators – Electrical Muscle Stimulators – Electrical Neuromuscular Incontinence Stimulators – Ultrasound Physical Therapy Devices – Ultrasound and Electrical Neuromuscular Stimulators – Magnetic Stimulators – Electromagnetic Stimulators – Stimulation Electrodes – Electromyograph (EMG) Biofeedback Device – Electromyograph (EMG) Biofeedback and Neuromuscular Stimulator – Shortwave Therapy Devices – Laser Therapy Devices’ accompanied by a falsified copy of CE certificate of conformity no. HD 60147882 0001, which would have been issued by Notified Body TÜV Rheinland LGA Products GmbH (0197) on 2021-06-03 and valid until 2025-06-21.
The valid EC Certificate of Conformity with No. HD 60147882 0001 HD 60147882 0001 was issued by Notified Body TÜV Rheinland LGA Products GmbH (0197) on 2020-08-03, valid until 2024-05-26, for the same product categories, belonged to manufacturer Shenzhen Dongdixin Technology Co., Ltd., China.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory ‘Clinical Electronic Thermometers – Infrared Ear/Forehead Thermometers – Infrared Ear Thermometers – Infrared Forehead Thermometers – Nerve and Muscle Stimulators – Electrical Acupuncture Stimulators – Transcutaneous Electrical Nerve Stimulators – Electrical Muscle Stimulators – Electrical Neuromuscular Incontinence Stimulators – Ultrasound Physical Therapy Devices – Ultrasound and Electrical Neuromuscular Stimulators – Magnetic Stimulators – Electromagnetic Stimulators – Stimulation Electrodes – Electromyograph (EMG) Biofeedback Device – Electromyograph (EMG) Biofeedback and Neuromuscular Stimulator – Shortwave Therapy Devices – Laser Therapy Devices’ based on the falsified copy of CE certificate of conformity no. HD 60147882 0001 HD 60147882 0001, do not use them and notify the National Agency for Medicines and Medical Devices of Romania – the Market Surveillance Service using the contact details posted on the NAMMDR website.