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Rheumatoid Factor IgM (RF IgM) Assay Reagent Kit (CMIA)
EUDAMEDClass IVD General (EU MDR)
Ref C2KB002
Identity
- Trade Name
- Rheumatoid Factor IgM (RF IgM) Assay Reagent Kit (CMIA) EUDAMED
- Model / Reference
- C2KB002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976753477465 EUDAMED
- Basic UDI-DI
- B-06976753477465 EUDAMED
- EMDN Code
- W01021110 RHEUMATOID FACTORS 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
Rheumatoid Factor IgM (RF IgM) Assay Reagent Kit (CMIA) 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-06976753477465 | 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 79e2213c-c920-467f-b907-655c4f63aa1a 61 fields · synced Oct 6, 2026