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RHEUMATOID FACTORS Kit
EUDAMEDClass IVD General (EU MDR)
Ref B45265Model RHEUMATOID FACTORS KitRef B28267Model RHEUMATOID FACTORS Kit 117mL
Identity
- Trade Name
- RHEUMATOID FACTORS Kit EUDAMED
- Device Name
- RHEUMATOID FACTORS Kit EUDAMED
- Model / Reference
- RHEUMATOID FACTORS Kit EUDAMEDB45265 EUDAMEDRHEUMATOID FACTORS Kit 117mL EUDAMEDB28267 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683555622594 EUDAMED08683555601926 EUDAMED
- Basic UDI-DI
- B-08683555622594 EUDAMEDB-08683555601926 EUDAMED
- EMDN Code
- W01021110 RHEUMATOID FACTORS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Türkiye 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 FACTORS Kit by Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇ — 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-08683555622594 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇
- EUDAMED SRN
- TR-MF-000040334
Sources (2)
- EUDAMED e94fc3e1-cb42-4427-9ca6-38b815f5b526 61 fields · synced Jul 17, 2026
- EUDAMED fdf651d0-5604-4559-84c9-48f059679631 61 fields · synced May 18, 2026