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Rheumatoid Factor IgM (RF IgM) Assay Reagent Kit (CMIA)
EUDAMEDClass IVD General (EU MDR)
Ref C2KI002
Identity
- Trade Name
- Rheumatoid Factor IgM (RF IgM) Assay Reagent Kit (CMIA) EUDAMED
- Model / Reference
- C2KI002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971792052499 EUDAMED
- Basic UDI-DI
- B-06971792052499 EUDAMED
- EMDN Code
- W01021110 RHEUMATOID FACTORS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain 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 Realy Tech Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Unknown
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06971792052499 | Class IVD General | Unknown |
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Manufacturer
- Manufacturer
- Hangzhou Realy Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000004716
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 3fb39798-2a6e-4875-9551-372fbd6187ff 61 fields · synced Jun 18, 2026