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α-Hydroxybutyrate Dehydrogenase Assay Kit (DGKC Method)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH040305Model R1: 20 mL×1; R2: 5 mL×1
Identity
- Device Name
- α-Hydroxybutyrate Dehydrogenase Assay Kit (DGKC Method) EUDAMED
- Model / Reference
- R1: 20 mL×1; R2: 5 mL×1 EUDAMEDDTSH040305 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225462848 EUDAMED
- Basic UDI-DI
- B-06975225462848 EUDAMED
- EMDN Code
- W01010118 HYDROXYBUTYRATE DEHYDROGENASE 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
α-Hydroxybutyrate Dehydrogenase Assay Kit (DGKC 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-06975225462848 | 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 (1)
- EUDAMED 05b12e01-d27b-440f-aa3a-975d349bebc6 61 fields · synced Jun 16, 2026