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Novel Coronavirus (COVID-19)IgG/IgM Rapid Test Device
EUDAMEDClass IVD General (EU MDR)
Ref A030501D
Identity
- Trade Name
- Novel Coronavirus (COVID-19)IgG/IgM Rapid Test Device EUDAMED
- Model / Reference
- A030501D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976753476116 EUDAMED
- Basic UDI-DI
- B-06976753476116 EUDAMED
- EMDN Code
- W0105040619 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
Novel Coronavirus (COVID-19)IgG/IgM Rapid Test Device by Hangzhou Cybereagen Biotech 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-06976753476116 | 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 77106a98-96fc-433b-8add-6805818de751 61 fields · synced Jun 18, 2026