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Alkaline Phosphatase Assay Kit (Rate Assay)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH020508Model R1: 40 mL×4; R2:10 mL×4Ref DTSH020509Model R1: 60 mL×2; R2:15 mL×2Ref DTSH020506Model R1: 40 mL×1; R2:10 mL×1Ref DTSH020501Model R1: 60 mL×4; R2:60 mL×1
Identity
- Device Name
- Alkaline Phosphatase Assay Kit (Rate Assay) EUDAMED
- Model / Reference
- R1: 40 mL×4; R2:10 mL×4 EUDAMEDDTSH020508 EUDAMEDR1: 60 mL×2; R2:15 mL×2 EUDAMEDDTSH020509 EUDAMEDR1: 40 mL×1; R2:10 mL×1 EUDAMEDDTSH020506 EUDAMEDR1: 60 mL×4; R2:60 mL×1 EUDAMEDDTSH020501 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225460967 EUDAMED06975225460974 EUDAMED06975225460943 EUDAMED06975225460998 EUDAMED
- Basic UDI-DI
- B-06975225460967 EUDAMEDB-06975225460974 EUDAMEDB-06975225460943 EUDAMEDB-06975225460998 EUDAMED
- EMDN Code
- W01010105 ALKALINE PHOSPHATASE - TOTAL 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
Alkaline Phosphatase Assay Kit (Rate Assay) 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-06975225460967 | 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 360e9e72-94f7-442f-8ca6-24a6594dd251 61 fields · synced Jul 26, 2026
- EUDAMED 907689ba-cda4-45e7-9f80-79ad8b7a478b 61 fields · synced May 16, 2026
- EUDAMED b61930c8-781b-4e09-b35a-c6767c693b40 61 fields · synced May 17, 2026
- EUDAMED 4990a3cc-a93c-45fc-86c0-b312360fe909 61 fields · synced May 17, 2026