Biotyx Medical (Shenzhen) Co., Ltd.
Active in EUDAMEDChinafrom SRN EUDAMED SRN CN-MF-000011475
- Devices
- 46
- Registrations
- EUDAMED
At a glance
EU certificates
2 of 2 in force.
Market reach
- European Union
- EUDAMED actor, 2 certificates
Catalogue
Search and filter all 46 devicesCompany details
- EUDAMED SRN
- CN-MF-000011475
- EUDAMED status
- Active since 2025
- EUDAMED registered name
- Biotyx Medical (Shenzhen) Co.,Ltd.
- Registered address
- 4F, Building No.4, Jinxiu Science Park, Wuhe Avenue, Longhua District, 518110, Shenzhen, China
- [email protected]
- PRRC contact
- Tony Li
EUDAMED certificates
2 certificates2 valid, 0 expiredMDR 2next expiry 1 Feb 2028
DEKRA Certification B.V. 0344 2 certificates
- 2245935CE01 Active
Quality management system EU MDR
- Issued
- 18 Aug 2023
- Expires
- 1 Feb 2028
- Reason
- Other
- 2245935TD01 Active
Technical documentation EU MDR
- Issued
- 18 Aug 2023
- Expires
- 1 Feb 2028
- Reason
- Other
Frequently asked questions
How many devices does Biotyx Medical (Shenzhen) Co.,Ltd. have in the registry?
The registry currently lists 46 devices for Biotyx Medical (Shenzhen) Co.,Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biotyx Medical (Shenzhen) Co.,Ltd.'s devices?
Among its 46 most recently registered devices, Biotyx Medical (Shenzhen) Co.,Ltd. has devices listed in EUDAMED (46 devices).
What risk classes do Biotyx Medical (Shenzhen) Co.,Ltd.'s devices fall under?
Among its 46 most recently registered devices, the classes recorded for Biotyx Medical (Shenzhen) Co.,Ltd.'s devices are Class III. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Biotyx Medical (Shenzhen) Co.,Ltd.?
EUDAMED lists 2 certificates for Biotyx Medical (Shenzhen) Co.,Ltd. (quality management system; technical documentation) under MDR. The most recent was issued on 18 Aug 2023.
What are the newest devices from Biotyx Medical (Shenzhen) Co.,Ltd. in the registry?
The most recently registered devices listed for Biotyx Medical (Shenzhen) Co.,Ltd. include IBS Angel.