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Rheumatoid Factor (RF) Serum Test
EUDAMEDClass IVD General (EU MDR)
Ref R15-112Ref R15-110
Identity
- Device Name
- Rheumatoid Factor (RF) Serum Test EUDAMED
- Model / Reference
- R15-112 EUDAMEDR15-110 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941571815010 EUDAMED06941571815003 EUDAMED
- Basic UDI-DI
- B-06941571815010 EUDAMEDB-06941571815003 EUDAMED
- EMDN Code
- W0102160699 RHEUMATOID / INFLAMMATORY DISEASE RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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 (RF) Serum Test by Ameritech Diagnostic Reagent (Jiaxing) 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-06941571815010 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
- EUDAMED SRN
- CN-MF-000020607
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (2)
- EUDAMED 87b4f8c1-da2d-408a-b888-ecd6b9ed9973 61 fields · synced Oct 6, 2026
- EUDAMED d20fb0cd-04a5-4a85-acac-7e813bbf86d4 61 fields · synced May 18, 2026