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2019-nCoV-IgG Assay Reagent Kit (CMIA)
EUDAMEDClass IVD General (EU MDR)
Ref C2KJ011
Identity
- Trade Name
- 2019-nCoV-IgG Assay Reagent Kit (CMIA) EUDAMED
- Device Name
- 2019-nCoV-IgG Assay Reagent Kit (CMIA) EUDAMED
- Model / Reference
- C2KJ011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971792050235 EUDAMED
- Basic UDI-DI
- B-06971792050235 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
2019-nCoV-IgG Assay Reagent Kit (CMIA) by Hangzhou Realy Tech 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-06971792050235 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Realy Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000004716
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 20e4f587-b80e-43a5-a8ea-103de1bbc724 61 fields · synced Oct 6, 2026