Ovulation Tests
by Tianjin New Bay Bioresearch Co., Ltd. 2 variants
Ref 14190
Active
CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06934142920077 06934142920077 | Date16 Apr 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Specification
- Model / Reference
- 14190
- Primary DI / UDI-DI
- 06934142920077
- Basic UDI-DI
- B-06934142920077
- EMDN Code
- W0102160304 Lh - rt & poc
- Device Class
- Class IVD devices for self-testing
- EU market of registration
- Northern Ireland
Manufacturer details
- EUDAMED SRN
- CN-MF-000040564
- Authorised representative
- MedEnvoy Global BV NL-AR-000024028
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Properties
Other properties (6)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No