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BIG KIT One Step Human Chorionic Gonadotropin (hCG) Pregnancy Test
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref BKHCGModel Cassette
Identity
- Trade Name
- BIG KIT One Step Human Chorionic Gonadotropin (hCG) Pregnancy Test EUDAMED
- Device Name
- One Step Human Chorionic Gonadotropin (hCG) Pregnancy Test EUDAMED
- Model / Reference
- Cassette EUDAMEDBKHCG EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08697962616374 EUDAMED
- Basic UDI-DI
- B-08697962616374 EUDAMED
- EMDN Code
- W0102160302 HCG - RT & POC EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
BIG KIT One Step Human Chorionic Gonadotropin (hCG) Pregnancy Test by Zet Medi̇kal Teksti̇l Diş Ti̇c. Ltd. Şti̇. — Class IVD devices for self-testing — IVDD…
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-08697962616374 | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Zet Medi̇kal Teksti̇l Diş Ti̇c. Ltd. Şti̇.
- EUDAMED SRN
- TR-MF-000046897
Sources (1)
- EUDAMED c8758f42-c843-466c-98d5-26b95ecd38dd 61 fields · synced Oct 6, 2026