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Rheumatoid Factor
EUDAMEDClass B (EU MDR)
Ref IRFA-5020Model IRFA-0230Ref RHFA-5M30Model RHFA-M130Ref RHFA-4220
Identity
- Trade Name
- RHEUMATOID FACTOR EUDAMED
- Device Name
- RHEUMATOID FACTOR EUDAMED
- Model / Reference
- IRFA-0230 EUDAMEDIRFA-5020 EUDAMEDRHFA-M130 EUDAMEDRHFA-5M30 EUDAMEDRHFA-4220 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03701700823612 EUDAMED03701700808015 EUDAMED03701700808039 EUDAMED03701700823605 EUDAMED
- Basic UDI-DI
- 37017008IRFA009E EUDAMED37017008RHFA019P EUDAMED
- EMDN Code
- W01021110 RHEUMATOID FACTORS EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMEDEUDAMED
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
New Device
No
EUDAMED
Rheumatoid Factor by Vitalscientific — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 37017008IRFA009E | Class B | Active |
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Manufacturer
- Manufacturer
- VitalScientific
- EUDAMED SRN
- FR-MF-000004722
Sources (4)
- EUDAMED 5d8d5e99-c2f4-4c7f-ac55-4303200d0c11 61 fields · synced Sep 17, 2026
- EUDAMED d70aac3f-5f6c-4e04-8b46-225072ff4b1b 61 fields · synced May 17, 2026
- EUDAMED 7d40b9b5-b4ec-4150-b6df-e216cd54d0a7 61 fields · synced May 18, 2026
- EUDAMED 9a777ab7-2845-4e58-8b72-5f261cd62330 61 fields · synced Jul 14, 2026