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HEV IgM Rapid Test Device (Serum/Plasma)
EUDAMEDClass IVD General (EU MDR)
Ref A401401D
Identity
- Trade Name
- HEV IgM Rapid Test Device (Serum/Plasma) EUDAMED
- Model / Reference
- A401401D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976753475591 EUDAMED
- Basic UDI-DI
- B-06976753475591 EUDAMED
- EMDN Code
- W0105020501 HEV ANTIGEN 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
HEV IgM Rapid Test Device (Serum/Plasma) by Hangzhou Cybereagen Biotech Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06976753475591 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Cybereagen Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000037850
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED b199ef55-3b5d-4992-9bbe-5965ebda4f00 61 fields · synced Jul 8, 2026