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Beta-Human Chorionic Gonadotropin (beta-hCG) Test Kit (Homogeneous Chemilumines…
EUDAMEDClass IVD General (EU MDR)
Ref HCLIA15118
Identity
- Trade Name
- Beta-Human Chorionic Gonadotropin (beta-hCG) Test Kit (Homogeneous Chemiluminescence Immunoassay) EUDAMED
- Device Name
- Beta-Human Chorionic Gonadotropin (beta-hCG) Test Kit (Homogeneous Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- HCLIA15118 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974524061776 EUDAMED
- Basic UDI-DI
- B-06974524061776 EUDAMED
- EMDN Code
- W0102050206 B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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 (beta-hCG) Test Kit (Homogeneous Chemilumines… by Nanjing Poclight Biotechnology Co., Ltd. — Class IVD General — 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-06974524061776 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Nanjing Poclight Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000039609
- Authorised Representative
- HUMISS TRADING S. L. ES-AR-000040177
Sources (1)
- EUDAMED 86a5c073-3eaa-449d-b370-ff3c57227466 61 fields · synced Jun 19, 2026