30.05.2024
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: ’Self tests – Rapid tests for self testing of infectious diseases : Candida Albicans (Yeast) Antigen Rapid Test Kit, Gardnerella Vaginalis Antigen Rapid Test Kit, Trichomonas Vaginalis Antigen Rapid Test Kit, Trichomonas V./ C.albs(yeast) / Gardnerella V.Ag Test Triple(3 in 1) STD panel Rapid Test Kit, Candida Albs (Yeast) / Gardnerella Vaginalis Antigen Combo (2/1) Rapid Test Kit, Fecal Occult Blood (FOB) Rapid Test, FSH Menopasure Rapid Test Kit for Home Usage, Hcg Pregnancy Rapid Test Kits for Home Usage,H. Pylori Antigen Detection, LH Ovulation Rapid Test Kts for Home Usage, Trichomoans V./ C.albs (yeast) Ag Test Combo (2 in 1) STI panel Rapid Test Kit, Standard Sexual Health Self Rapid Urine Test (7 in 1)’ manufactured by Jei Daniel (JD) Biotech Corp., China, for which they have come into possession of the falsified copy of the EC certificate of conformity no. V1 063963 0008 Rev. 00 which would have been issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123) on 2020-08-16, valid from 2020-09-04 to 2025-09-03 for this manufacturer.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory ’Self tests – Rapid tests for self testing of infectious diseases : Candida Albicans (Yeast) Antigen Rapid Test Kit, Gardnerella Vaginalis Antigen Rapid Test Kit, Trichomonas Vaginalis Antigen Rapid Test Kit, Trichomonas V./ C.albs(yeast) / Gardnerella V.Ag Test Triple(3 in 1) STD panel Rapid Test Kit, Candida Albs (Yeast) / Gardnerella Vaginalis Antigen Combo (2/1) Rapid Test Kit, Fecal Occult Blood (FOB) Rapid Test, FSH Menopasure Rapid Test Kit for Home Usage, Hcg Pregnancy Rapid Test Kits for Home Usage,H. Pylori Antigen Detection, LH Ovulation Rapid Test Kts for Home Usage, Trichomoans V./ C.albs (yeast) Ag Test Combo (2 in 1) STI panel Rapid Test Kit, Standard Sexual Health Self Rapid Urine Test (7 in 1)’ from manufacturer Jei Daniel (JD) Biotech Corp., China, based on the falsified copy of the CE certificate, 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.
The valid certificate, held by this manufacturer, has the same number, was issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123), valid from 2018-09-04 to 2023-09-03 and covers only the following product categories: Self tests – Rapid tests for self-testing of infectious diseases : Candida Albicans (Yeast) Antigen Rapid Test Kit, Gardnerella Vaginalis Antigen Rapid Test Kit, Trichomonas Vaginalis Antigen Rapid Test Kit, Trichomonas V./ C.albs(yeast) / Gardnerella V.Ag Test Triple(3 in 1) STD panel Rapid Test Kit, Candida Albs (Yeast) / Gardnerella Vaginalis Antigen Combo (2/1) Rapid Test Kit, Fecal Occult Blood (FOB) Rapid Test, FSH Menopasure Rapid Test Kit for Home Usage, Hcg Pregnancy Rapid Test Kits for Home Usage,H. Pylori Antigen Detection, LH Ovulation Rapid Test Kts for Home Usage, Trichomoans V./ C.albs (yeast) Ag Test Combo (2 in 1) STI panel Rapid Test Kit, Trichomonas V /Gardnerella V Antigen Combo (2/1) Rapid Test Kit.
For personal 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
National Agency for Medicines and Medical Devices of Romania
