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β Human Chorionic Gonadotropin (β-HCG) Test Kit (Immunofluorescence Method)
EUDAMEDClass IVD General (EU MDR)
Ref W-IF2-β-HCG-20Model 20 tests/kitRef W-IF2-β-HCG-40Model 40 tests/kitRef W-IF-β-HCG-40
Identity
- Trade Name
- β Human Chorionic Gonadotropin (β-HCG) Test Kit (Immunofluorescence Method) EUDAMED
- Device Name
- β Human Chorionic Gonadotropin (β-HCG) Test Kit (Immunofluorescence Method) EUDAMEDMonkeypox Virus Antigen Rapid Test Kit EUDAMED
- Model / Reference
- 20 tests/kit EUDAMEDW-IF2-β-HCG-20 EUDAMED40 tests/kit EUDAMEDW-IF2-β-HCG-40 EUDAMEDW-IF-β-HCG-40 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978896415809 EUDAMED06978896415816 EUDAMED06973720131634 EUDAMED
- Basic UDI-DI
- B-06978896415809 EUDAMEDB-06978896415816 EUDAMEDB-06973720131634 EUDAMED
- EMDN Code
- W0102050206 B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT) EUDAMEDW0102050299 PREGNANCY TESTING HORMONES - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMEDEUDAMED
Microbial Substances
No
EUDAMEDEUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
β Human Chorionic Gonadotropin (β-HCG) Test Kit (Immunofluorescence Method) by Wuhan Easydiagnosis Biomedicine Co., Ltd. — Class IVD General — IVDD — listed…
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-06978896415809 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Wuhan Easydiagnosis Biomedicine Co., Ltd.
- EUDAMED SRN
- CN-MF-000019908
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (3)
- EUDAMED e072f094-93bc-42aa-8d33-214bc357fb4b 61 fields · synced Oct 6, 2026
- EUDAMED 74fd19d7-9e64-4e52-b3d7-4b09b4fdb820 61 fields · synced May 18, 2026
- EUDAMED 1ad5ec7d-fda6-4f81-a2f3-927425b0f3e2 61 fields · synced May 18, 2026