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α-Hydroxybutyrate Dehydrogenase Assay Kit (DGKC Method)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH040306Model R1: 40 mL×1; R2: 10 mL×1Ref DTSH040301Model R1: 60 mL×4; R2: 15 mL×4Ref DTSH040303Model R1: 80 mL×4; R2: 80 mL×1Ref DTSH040307Model R1: 60 mL×1; R2: 15 mL×1
Identity
- Device Name
- α-Hydroxybutyrate Dehydrogenase Assay Kit (DGKC Method) EUDAMED
- Model / Reference
- R1: 40 mL×1; R2: 10 mL×1 EUDAMEDDTSH040306 EUDAMEDR1: 60 mL×4; R2: 15 mL×4 EUDAMEDDTSH040301 EUDAMEDR1: 80 mL×4; R2: 80 mL×1 EUDAMEDDTSH040303 EUDAMEDR1: 60 mL×1; R2: 15 mL×1 EUDAMEDDTSH040307 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225462855 EUDAMED06975225462893 EUDAMED06975225462916 EUDAMED06975225462862 EUDAMED
- Basic UDI-DI
- B-06975225462855 EUDAMEDB-06975225462893 EUDAMEDB-06975225462916 EUDAMEDB-06975225462862 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-06975225462855 | 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 fa41627d-08c1-43b2-9439-fecb13137c14 61 fields · synced Aug 2, 2026
- EUDAMED ee787827-8bdd-4ccc-aae2-3248e31ebe0b 61 fields · synced May 17, 2026
- EUDAMED 3c61c6a4-52d9-4b12-9d22-2de23f8d2a2e 61 fields · synced May 18, 2026
- EUDAMED 9a3f4987-0231-499b-8ebd-d61c504f1b71 61 fields · synced May 18, 2026