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Glucose Assay Kit (Glucose Oxidase Method)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH010105Model R: 60 mL×2Ref DTSH010107Model R: 60 mL×6Ref DTSH010108Model R: 90 mL×4
Identity
- Device Name
- Glucose Assay Kit (Glucose Oxidase Method) EUDAMED
- Model / Reference
- R: 60 mL×2 EUDAMEDDTSH010105 EUDAMEDR: 60 mL×6 EUDAMEDDTSH010107 EUDAMEDR: 90 mL×4 EUDAMEDDTSH010108 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225461469 EUDAMED06975225461490 EUDAMED06975225461506 EUDAMED
- Basic UDI-DI
- B-06975225461469 EUDAMEDB-06975225461490 EUDAMEDB-06975225461506 EUDAMED
- EMDN Code
- W01010213 GLUCOSE 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
Glucose Assay Kit (Glucose 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-06975225461469 | 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 eb85f71b-1b77-4eed-b594-167a4dbf7f1c 61 fields · synced Jul 29, 2026
- EUDAMED 69fedf5d-3b6a-40aa-9e91-1fadcd7e9300 61 fields · synced May 17, 2026
- EUDAMED 552f5632-8159-419d-b29d-f28e2aa2f200 61 fields · synced May 18, 2026