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C-Reactive Protein Assay Kit (Immunoturbidimetric Method)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH050108Model R1: 40 mL×4; R2: 10 mL×4Ref DTSH050110Model R1: 60 mL×4; R2: 15 mL×4Ref DTSH050106Model R1: 40 mL×1; R2: 10 mL×1Ref DTSH050109Model R1: 60 mL×2; R2: 15 mL×2
Identity
- Device Name
- C-Reactive Protein Assay Kit (Immunoturbidimetric Method) EUDAMED
- Model / Reference
- R1: 40 mL×4; R2: 10 mL×4 EUDAMEDDTSH050108 EUDAMEDR1: 60 mL×4; R2: 15 mL×4 EUDAMEDDTSH050110 EUDAMEDR1: 40 mL×1; R2: 10 mL×1 EUDAMEDDTSH050106 EUDAMEDR1: 60 mL×2; R2: 15 mL×2 EUDAMEDDTSH050109 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225462107 EUDAMED06975225462121 EUDAMED06975225462084 EUDAMED06975225462114 EUDAMED
- Basic UDI-DI
- B-06975225462107 EUDAMEDB-06975225462121 EUDAMEDB-06975225462084 EUDAMEDB-06975225462114 EUDAMED
- EMDN Code
- W01021109 C-REACTIVE PROTEIN 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
C-Reactive Protein 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-06975225462107 | 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 (4)
- EUDAMED 1f823524-2883-408a-bbaa-fd44efd2e938 61 fields · synced Jul 29, 2026
- EUDAMED 9cf0c487-6cca-49d4-b1da-0ed19a50a290 61 fields · synced May 17, 2026
- EUDAMED d037a7e7-f603-41c7-b52b-a2e9f4126138 61 fields · synced May 19, 2026
- EUDAMED 5c2d3ca2-9579-4c1f-8bed-1c38fd345776 61 fields · synced May 19, 2026