Innovita (Tangshan) Biological Technology Co., Ltd.
Active in EUDAMEDChinafrom SRN EUDAMED FDA SRN CN-MF-000018424 FEI 3013332582
- Devices
- 21
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
EU certificates
4 of 4 in force.
Market reach
- European Union
- EUDAMED actor, 4 certificates
- United States
- FDA FEI
Catalogue
Search and filter all 21 devicesCompany details
- EUDAMED SRN
- CN-MF-000018424
- FDA FEI number
- 3013332582
- DUNS number
- 554456128
- EUDAMED status
- Active
- EUDAMED registered name
- Innovita (Tangshan) Biological Technology Co., Ltd.
- EUDAMED abbreviated name
- Innovita
- Registered address
- No. 699 Juxin Street, High-Tech Industrial Development Zone,, 064400, Qian'an, Hebei,, China
- Website
- www.innovitaivd.com.cn
- [email protected]
- Phone
- +86-10-83681277
- PRRC contact
- Kang Gao
EUDAMED certificates
4 certificates4 valid, 0 expiredIVDR 4next expiry 11 Mar 2030
TÜV Rheinland LGA Products GmbH 0197 4 certificates
- IX 2006076-3 Active
Technical documentation EU IVDR
- Issued
- 16 Jun 2026
- Expires
- 15 Jun 2031
- HX 2006076-1 Active
Quality management system EU IVDR
- Issued
- 16 Jun 2026
- Expires
- 11 Mar 2030
- Reason
- Add device or group
- IX 2006076-1 Active
Technical documentation EU IVDR
- Issued
- 12 Mar 2025
- Expires
- 11 Mar 2030
- IX 2006076-2 Active
Technical documentation EU IVDR
- Issued
- 12 Mar 2025
- Expires
- 11 Mar 2030
Frequently asked questions
How many devices does Innovita (Tangshan) Biological Technology Co., Ltd. have in the registry?
The registry currently lists 21 devices for Innovita (Tangshan) Biological Technology Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Innovita (Tangshan) Biological Technology Co., Ltd.'s devices?
Among its 21 most recently registered devices, Innovita (Tangshan) Biological Technology Co., Ltd. has devices listed in EUDAMED (16 devices), FDA 510(k) (3 devices) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Innovita (Tangshan) Biological Technology Co., Ltd.'s devices fall under?
Among its 21 most recently registered devices, the classes recorded for Innovita (Tangshan) Biological Technology Co., Ltd.'s devices are Class II, IVDR Class B and IVDR Class C. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Innovita (Tangshan) Biological Technology Co., Ltd.?
EUDAMED lists 4 certificates for Innovita (Tangshan) Biological Technology Co., Ltd. (technical documentation; quality management system) under IVDR. 3 are recorded with the status issued. The most recent was issued on 16 Jun 2026.
What are the newest devices from Innovita (Tangshan) Biological Technology Co., Ltd. in the registry?
The most recently registered devices listed for Innovita (Tangshan) Biological Technology Co., Ltd. include INNOVITA, INNOVITA YF335C155, INNOVITA YF107C086 and HCG Pregnancy Rapid Tests for self-testing.