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2019-nCoV IgG/IgM DetectionKit (Colloidal Gold-Based）
EUDAMEDClass IVD General (EU MDR)
Ref C6603C
Identity
- Trade Name
- 2019-nCoV IgG/IgM DetectionKit (Colloidal Gold-Based） EUDAMED2019-nCoV IgG/IgM Detection Kit (Colloidal Gold-Based） EUDAMED
- Device Name
- 2019-nCoV IgG/IgM DetectionKit (Colloidal Gold-Based） EUDAMED2019-nCoV IgG/IgM Detection Kit (Colloidal Gold-Based） EUDAMED
- Model / Reference
- C6603C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973315730747 EUDAMED
- Basic UDI-DI
- B-06973315730747 EUDAMED
- EMDN Code
- W0105090502 CORONAVIRUS ANTIBODY (AB) - RT & POC 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
2019-nCoV IgG/IgM DetectionKit (Colloidal Gold-Based） by Nanjing Vazyme Medical Technology 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-06973315730747 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Nanjing Vazyme Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000031032
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED eb0a7573-6ee3-4c98-9d0e-89a80a634b84 61 fields · synced Oct 6, 2026
- EUDAMED 306dc697-2161-4d10-8c78-6a2b10eaf18e 61 fields · synced Oct 6, 2026