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Glucose Assay Kit (Hexokinase Method)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH010211Model R1: 60 mL×4; R2: 60 mL×1Ref DTSH010207Model R1: 60 mL×1; R2: 15 mL×1Ref DTSH010203Model R1: 80 mL×4; R2: 80 mL×1Ref DTSH010208Model R1: 40 mL×4; R2: 10 mL×4Ref DTSH010205Model R1: 20 mL×1; R2: 5 mL×1Ref DTSH010209Model R1: 60 mL×2; R2: 15 mL×2
Identity
- Device Name
- Glucose Assay Kit (Hexokinase Method) EUDAMED
- Model / Reference
- R1: 60 mL×4; R2: 60 mL×1 EUDAMEDDTSH010211 EUDAMEDR1: 60 mL×1; R2: 15 mL×1 EUDAMEDDTSH010207 EUDAMEDR1: 80 mL×4; R2: 80 mL×1 EUDAMEDDTSH010203 EUDAMEDR1: 40 mL×4; R2: 10 mL×4 EUDAMEDDTSH010208 EUDAMEDR1: 20 mL×1; R2: 5 mL×1 EUDAMEDDTSH010205 EUDAMEDR1: 60 mL×2; R2: 15 mL×2 EUDAMEDDTSH010209 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225461971 EUDAMED06975225461933 EUDAMED06975225461988 EUDAMED06975225461940 EUDAMED06975225461919 EUDAMED06975225461957 EUDAMED
- Basic UDI-DI
- B-06975225461971 EUDAMEDB-06975225461933 EUDAMEDB-06975225461988 EUDAMEDB-06975225461940 EUDAMEDB-06975225461919 EUDAMEDB-06975225461957 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 (Hexokinase Method) by Da Te Bioengineering Technology Co., LTD. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06975225461971 | 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 (6)
- EUDAMED 4c085681-2b6d-4bb5-8977-326c9a315750 61 fields · synced Aug 1, 2026
- EUDAMED 5a95511d-17b6-45bc-b894-d5be3c719563 61 fields · synced May 17, 2026
- EUDAMED e94545ce-7247-47f1-94a0-a83625b499d6 61 fields · synced May 17, 2026
- EUDAMED 6467aab5-3b76-41f6-9849-910ed9a3d969 61 fields · synced May 18, 2026
- EUDAMED d4c54cdf-b69d-4c26-a880-a116a1371eb8 61 fields · synced May 18, 2026
- EUDAMED 35ee76b8-ee82-4571-92ab-595ccc80c6c8 61 fields · synced May 18, 2026