← Back to catalogue
2019-nCOV IgGIgM Rapid Test Device (whole blood +2 more)
EUDAMEDClass IVD General (EU MDR)
Ref A190501D
Identity
- Trade Name
- 2019-nCOV IgGIgM Rapid Test Device (whole blood/serum/plasma) EUDAMED
- Model / Reference
- A190501D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976753473191 EUDAMED
- Basic UDI-DI
- B-06976753473191 EUDAMED
- EMDN Code
- W0105040619 EUDAMED
- Models / Variants
- whole blood EUDAMEDserum EUDAMEDplasma 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
2019-nCOV IgGIgM Rapid Test Device (whole blood +2 more) by Hangzhou Cybereagen Biotech Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — 3 models
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-06976753473191 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
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 c28ba286-3dca-46b3-8691-a4ccab34975c 61 fields · synced Oct 5, 2026