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Beta Human Chorionic Gonadotropin Test Kit
EUDAMEDClass IVD General (EU MDR)
Ref G1402CVRef G1402CCRef G1403CC
Identity
- Trade Name
- Beta Human Chorionic Gonadotropin Test Kit EUDAMED
- Device Name
- Beta Human Chorionic Gonadotropin Test Kit EUDAMED
- Model / Reference
- G1402CV EUDAMEDG1402CC EUDAMEDG1403CC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973315739139 EUDAMED06979469761545 EUDAMED06979469761569 EUDAMED
- Basic UDI-DI
- B-06973315739139 EUDAMEDB-06979469761545 EUDAMEDB-06979469761569 EUDAMED
- EMDN Code
- W0102050206 B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Beta Human Chorionic Gonadotropin Test Kit by Nanjing Vazyme Medical Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06973315739139 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Nanjing Vazyme Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000031032
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (3)
- EUDAMED f2fa1199-7e1f-4f0c-8bf4-352786fd4eb2 61 fields · synced Oct 6, 2026
- EUDAMED af5d074e-c4f0-4e6a-a446-50c5450c724e 61 fields · synced Jul 25, 2026
- EUDAMED 4ff65000-92f4-4356-93e0-de94f1026650 61 fields · synced Jul 27, 2026