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Rheumatoid Factor Kit（latex Enhanced Immunoturbidimetric Assay）
EUDAMEDClass IVD General (EU MDR)
Ref 3012518Model R1: 1x40mL, R2: 1x10mLRef 3001013Ref 3021694Model R1: 1x40mL, R2: 1x10mL, Calibration sample: 1x1mL,Ref 3021190Model R1: 1x40mL, R2: 1x10mL, Calibration sample: 1x1mL, Ref 3023206Ref 3016530
Identity
- Trade Name
- RHEUMATOID FACTOR KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY） EUDAMED
- Device Name
- RHEUMATOID FACTOR KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY） EUDAMED
- Model / Reference
- R1: 1x40mL, R2: 1x10mL EUDAMED3012518 EUDAMED3001013 EUDAMEDR1: 1x40mL, R2: 1x10mL, Calibration sample: 1x1mL, EUDAMED3021694 EUDAMED3021190 EUDAMED3023206 EUDAMED3016530 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202260179 EUDAMED06942202246821 EUDAMED06925794592767 EUDAMED06942202260155 EUDAMED06942202213311 EUDAMED06942202260162 EUDAMED
- Basic UDI-DI
- B-06942202260179 EUDAMEDB-06942202246821 EUDAMEDB-06925794592767 EUDAMEDB-06942202260155 EUDAMEDB-06942202213311 EUDAMEDB-06942202260162 EUDAMED
- EMDN Code
- W01021110 RHEUMATOID FACTORS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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 Kit（latex Enhanced Immunoturbidimetric Assay） by Dirui Industrial 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-06942202260179 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (6)
- EUDAMED bf97e74e-7d7d-4efa-8107-610e3a7fdada 61 fields · synced Aug 3, 2026
- EUDAMED 8ed4251d-7591-414f-8d94-c755e781e47b 61 fields · synced May 17, 2026
- EUDAMED dc19ce4e-158f-4453-b141-ecf799ee7d6a 61 fields · synced Jul 9, 2026
- EUDAMED f7b91142-4f26-45f5-9723-7ad37e6c9cbe 61 fields · synced Jul 14, 2026
- EUDAMED 1441900c-3613-41fc-9f13-4aff6e77e54f 61 fields · synced Aug 2, 2026
- EUDAMED 4e1a4e69-e468-44af-958b-182df33b3cae 61 fields · synced Aug 3, 2026