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Rapid Test for IgM Antibody to Hepatitis E Virus (Colloidal Gold Device)
EUDAMEDClass IVD General (EU MDR)
Ref WE-1510
Identity
- Device Name
- Rapid Test for IgM Antibody to Hepatitis E Virus (Colloidal Gold Device) EUDAMED
- Model / Reference
- WE-1510 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970301452560 EUDAMED
- Basic UDI-DI
- B-06970301452560 EUDAMED
- EMDN Code
- W0105020505 HEV ANTIBODY IGM EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
Rapid Test for IgM Antibody to Hepatitis E Virus (Colloidal Gold Device) by Beijing Wantai Biological Pharmacy Enterprise 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-06970301452560 | Class IVD General | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000040626
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED 7c50523a-b97f-4f9e-91b5-9e63343e058f 61 fields · synced Oct 6, 2026