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Creatinine Assay Kit (Picric Acid Method)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH030101Model R1: 60 mL×4; R2: 60 mL×1Ref DTSH030108Model R1: 40 mL×4; R2: 10 mL×4Ref DTSH030106Model R1: 40 mL×1; R2: 10 mL×1Ref DTSH030103Model R1: 80 mL×4; R2: 80 mL×1Ref DTSH030102Model R1: 60 mL×4; R2: 15 mL×4Ref DTSH030109Model R1: 60 mL×2; R2: 15 mL×2Ref DTSH030105Model R1: 20 mL×1; R2: 5 mL×1
Identity
- Device Name
- Creatinine Assay Kit (Picric Acid Method) EUDAMED
- Model / Reference
- R1: 60 mL×4; R2: 60 mL×1 EUDAMEDDTSH030101 EUDAMEDR1: 40 mL×4; R2: 10 mL×4 EUDAMEDDTSH030108 EUDAMEDR1: 40 mL×1; R2: 10 mL×1 EUDAMEDDTSH030106 EUDAMEDR1: 80 mL×4; R2: 80 mL×1 EUDAMEDDTSH030103 EUDAMEDR1: 60 mL×4; R2: 15 mL×4 EUDAMEDDTSH030102 EUDAMEDR1: 60 mL×2; R2: 15 mL×2 EUDAMEDDTSH030109 EUDAMEDR1: 20 mL×1; R2: 5 mL×1 EUDAMEDDTSH030105 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225461070 EUDAMED06975225461049 EUDAMED06975225461025 EUDAMED06975225461087 EUDAMED06975225461063 EUDAMED06975225461056 EUDAMED06975225461018 EUDAMED
- Basic UDI-DI
- B-06975225461070 EUDAMEDB-06975225461049 EUDAMEDB-06975225461025 EUDAMEDB-06975225461087 EUDAMEDB-06975225461063 EUDAMEDB-06975225461056 EUDAMEDB-06975225461018 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
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
Creatinine Assay Kit (Picric Acid 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-06975225461070 | 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 (7)
- EUDAMED 2e89de0a-1ffe-4620-a85e-917b0e549e5d 61 fields · synced Aug 2, 2026
- EUDAMED c1f4f024-2849-4a46-a566-a586b03a0971 61 fields · synced May 16, 2026
- EUDAMED 2629cc46-dc9d-4679-84fa-0a9a41bd8477 61 fields · synced May 16, 2026
- EUDAMED a50de97c-3689-49db-9e96-5e207e469fad 61 fields · synced May 17, 2026
- EUDAMED 6bc733fc-8001-4c80-988e-8e51fd0870f5 61 fields · synced May 18, 2026
- EUDAMED 4c354963-2707-4b64-a0e8-857ab5e6c6fd 61 fields · synced May 19, 2026
- EUDAMED c13938bd-ee41-49cf-bb28-a8e60d78f579 61 fields · synced May 19, 2026