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Creatinine Assay Kit (Sarcosine Oxidase Method)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH030207Model R1: 45 mL×1; R2: 15 mL×1Ref DTSH030209Model R1: 60 mL×2; R2: 20 mL×2Ref DTSH030204Model R1: 80 mL×3; R2: 80 mL×1Ref DTSH030208Model R1: 30 mL×3; R2: 30 mL×1Ref DTSH030201Model R1: 60 mL×4; R2: 20 mL×4
Identity
- Device Name
- Creatinine Assay Kit (Sarcosine Oxidase Method) EUDAMED
- Model / Reference
- R1: 45 mL×1; R2: 15 mL×1 EUDAMEDDTSH030207 EUDAMEDR1: 60 mL×2; R2: 20 mL×2 EUDAMEDDTSH030209 EUDAMEDR1: 80 mL×3; R2: 80 mL×1 EUDAMEDDTSH030204 EUDAMEDR1: 30 mL×3; R2: 30 mL×1 EUDAMEDDTSH030208 EUDAMEDR1: 60 mL×4; R2: 20 mL×4 EUDAMEDDTSH030201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225462787 EUDAMED06975225462800 EUDAMED06975225462831 EUDAMED06975225462794 EUDAMED06975225462824 EUDAMED
- Basic UDI-DI
- B-06975225462787 EUDAMEDB-06975225462800 EUDAMEDB-06975225462831 EUDAMEDB-06975225462794 EUDAMEDB-06975225462824 EUDAMED
- EMDN Code
- W01010207 CREATININE 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
Creatinine Assay Kit (Sarcosine Oxidase 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-06975225462787 | 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 a7978280-ef77-4291-80a8-ad990a4df7f8 61 fields · synced Jul 17, 2026
- EUDAMED 5eed48dd-7721-4a5d-978f-418eeba360a4 61 fields · synced May 16, 2026
- EUDAMED ea87f2f2-1a0f-4c23-99a7-4bf8a33678a2 61 fields · synced May 17, 2026
- EUDAMED f494a0cd-31ae-458c-9c36-e19a34a9699a 61 fields · synced May 18, 2026
- EUDAMED 86984755-4f0c-4fbd-8a50-6157b76c9488 61 fields · synced May 19, 2026