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Uric Acid Assay Kit (Oxidase Method)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH030904Model R1: 40 mL×4; R2: 10 mL×4Ref DTSH030906Model R1: 60 mL×4; R2: 15 mL×4Ref DTSH030901Model R1: 20 mL×1; R2: 5 mL×1
Identity
- Device Name
- Uric Acid Assay Kit (Oxidase Method) EUDAMED
- Model / Reference
- R1: 40 mL×4; R2: 10 mL×4 EUDAMEDDTSH030904 EUDAMEDR1: 60 mL×4; R2: 15 mL×4 EUDAMEDDTSH030906 EUDAMEDR1: 20 mL×1; R2: 5 mL×1 EUDAMEDDTSH030901 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225461414 EUDAMED06975225461438 EUDAMED06975225461384 EUDAMED
- Basic UDI-DI
- B-06975225461414 EUDAMEDB-06975225461438 EUDAMEDB-06975225461384 EUDAMED
- EMDN Code
- W01010232 URIC ACID EUDAMEDW01010230 TOTAL 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
Category: Uric acid IVD, reagent
Uric Acid Assay Kit (Oxidase Method) by Da Te Bioengineering Technology Co., LTD. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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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-06975225461414 | 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 (3)
- EUDAMED 7b82bb61-ed56-4257-b4fc-dfaba742af90 61 fields · synced Jul 18, 2026
- EUDAMED 14261382-86f7-4f0c-87e0-58febd01b4a6 61 fields · synced May 17, 2026
- EUDAMED 9d198674-7c93-442d-9dd5-e11ad3fc2a8f 61 fields · synced May 18, 2026