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Rheumatoid Factor Assay Kit (Immunoturbidimetric Method)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH090211Model R1: 80 mL×4; R2: 80 mL×1Ref DTSH090201Model R1: 60 mL×4; R2: 60 mL×1Ref DTSH090206Model R1: 40 mL×1; R2: 10 mL×1Ref DTSH090207Model R1: 60 mL×1; R2: 15 mL×1Ref DTSH090205Model R1: 20 mL×1; R2: 5 mL×1
Identity
- Device Name
- Rheumatoid Factor Assay Kit (Immunoturbidimetric Method) EUDAMED
- Model / Reference
- R1: 80 mL×4; R2: 80 mL×1 EUDAMEDDTSH090211 EUDAMEDR1: 60 mL×4; R2: 60 mL×1 EUDAMEDDTSH090201 EUDAMEDR1: 40 mL×1; R2: 10 mL×1 EUDAMEDDTSH090206 EUDAMEDR1: 60 mL×1; R2: 15 mL×1 EUDAMEDDTSH090207 EUDAMEDR1: 20 mL×1; R2: 5 mL×1 EUDAMEDDTSH090205 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225461902 EUDAMED06975225461896 EUDAMED06975225461841 EUDAMED06975225461858 EUDAMED06975225461834 EUDAMED
- Basic UDI-DI
- B-06975225461902 EUDAMEDB-06975225461896 EUDAMEDB-06975225461841 EUDAMEDB-06975225461858 EUDAMEDB-06975225461834 EUDAMED
- EMDN Code
- W01021110 RHEUMATOID FACTORS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
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 Assay Kit (Immunoturbidimetric Method) by Da Te Bioengineering Technology 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-06975225461902 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Da Te Bioengineering Technology Co., LTD.
- EUDAMED SRN
- CN-MF-000028832
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (5)
- EUDAMED 9638c711-568a-42f0-b637-bf7657147c8f 61 fields · synced Jul 23, 2026
- EUDAMED 03d046ef-6788-4d1b-8299-4a9650a0d59e 61 fields · synced May 16, 2026
- EUDAMED 4ce05210-36b3-44c3-9c04-a93b769ac0bb 61 fields · synced May 17, 2026
- EUDAMED d20e1c36-e7d4-4fc2-8083-016e567dd2b1 61 fields · synced May 18, 2026
- EUDAMED 9fd333c1-552b-4b4d-8ef9-b020411cc972 61 fields · synced May 18, 2026