EUDAMED registration D-CNMF000016915YKAA6VYesOptical Coherence Tomographer
- Risk class
- Class IIa
- CND nomenclatures code
- Q0299
- Implantable
- No
- Reusable
- No
- Measuring function
- Yes
- Primary DI
- D-CNMF000016915YKAA6V
- Basic UDI
- B-CNMF000016915YKAA6V
- Version date
- March 24, 2023
- Manufacturer last update
- March 23, 2023
- Active status
- Yes
- Manufacturer name
- Shenzhen CERTAINN Technology Co., Ltd.
- Country
- China
- Country type
- NON_EU
- Address
- Tangtou 1st Road L302,Bldg.2,Skyworth Innovation Valley,No.8 Tangtou 1st Road,Tangtou Community,Shiyan Subdistrict,Bao'an District, 518108 Shenzhen,PEOPLE'S REPUBLIC OF CHINA Shenzhen
- qms-engineer@moptim.cn
- SRN
- DE-AR-000000001
- Country
- Germany
- Address
- 80 Eiffestraße Hamburg
- shholding@hotmail.com
- Telephone
- +49 40 2513175
- Competent authority
- DE/CA05 - Behorde fur Justiz und Verbraucherschutz
- Applicable legislation
- MDD (Directive 93/42/EEC on Medical Devices)
- Placed on the market
- Greece
- Market available
- Greece:2021-07-23~2023-03-24
- Human tissues
- No
- Animal tissues
- No
OPHTHALMIC DEVICES - OTHER
Access comprehensive regulatory information for Optical Coherence Tomographer in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI D-CNMF000016915YKAA6V and manufactured by Shenzhen CERTAINN Technology Co., Ltd. in China.
This page provides complete registration details including manufacturer information, authorized representative details, competent authority (DE/CA05 - Behorde fur Justiz und Verbraucherschutz), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.