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α-Hydroxybutyrate Dehydrogenase (α-HBDH) Test Kit (DGKC)
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref R1:64mL×2 R2:16mL×2（701）
Identity
- Trade Name
- α-Hydroxybutyrate Dehydrogenase (α-HBDH) Test Kit (DGKC) EUDAMEDBIOBASE FDA UDI
- Generic Name
- Alpha-hydroxybutyrate dehydrogenase IVD, reagent FDA UDI
- Device Name
- α-Hydroxybutyrate Dehydrogenase (α-HBDH) Test Kit (DGKC) EUDAMED
- Model / Reference
- R1:64mL×2 R2:16mL×2（701） EUDAMEDR1:64mL×2 R2:16mL×2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971674863397 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06971674863397 EUDAMED
- FDA Product Code
- JMK FDA UDI
- EMDN Code
- W01010118 HYDROXYBUTYRATE DEHYDROGENASE EUDAMED
- GMDN Term
- Alpha-hydroxybutyrate dehydrogenase IVD, reagent FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1380 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
α-Hydroxybutyrate Dehydrogenase (α-HBDH) Test Kit (DGKC) by Biobase Biodustry(Shandong) Co., Ltd. — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA…
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06971674863397 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Biobase Biodustry(Shandong) Co., Ltd.
- EUDAMED SRN
- CN-MF-000025015
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (2)
- EUDAMED a4e4c20b-0c32-488d-9fcd-5225fc07f74f 61 fields · synced Oct 6, 2026
- FDA UDI 670e54c3-c2c1-4a03-a9b8-ea22818564a0 32 fields · synced May 30, 2026