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α-Hydroxybutyrate Dehydrogenase (α-HBDH) Test Kit (DGKC)

by Biobase Biodustry(Shandong) Co., Ltd. 13 variants

Ref R1:48mL×2 R2:12mL×2（705）

Active European Union. Also listed in GUDID (US).

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-06971674863434 Basic UDI-DI 06971674863434UDI-DIDate30 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06971674863434 UDI-DI Date21 Jul 2023ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
α-Hydroxybutyrate Dehydrogenase (α-HBDH) Test Kit (DGKC) EUDAMED
Biobase GUDID
Generic Name
Alpha-hydroxybutyrate dehydrogenase IVD, reagent
Model / Reference
R1:48mL×2 R2:12mL×2（705） EUDAMED
R1:48mL×2 R2:12mL×2 GUDID
Primary DI / UDI-DI
06971674863434
Basic UDI-DI
B-06971674863434
FDA Product Code
JMK
EMDN Code
W01010118 Hydroxybutyrate dehydrogenase
GMDN Term
Alpha-hydroxybutyrate dehydrogenase IVD, reagent
Device Class
Class IVD General EUDAMED
Class I GUDID
Regulation Number
862.1380
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
R1:48mL×2 R2:12mL×2（705）
GUDID
R1:48mL×2 R2:12mL×2
Device ClassEUDAMED
Class IVD General
GUDID
Class I

Manufacturer details

EUDAMED SRN
CN-MF-000025015
Authorised representative
Luxus Lebenswelt GmbH DE-AR-000005110

Other devices from Biobase Biodustry(Shandong) Co., Ltd.

See all devices from Biobase Biodustry(Shandong) Co., Ltd. →

Properties

  • Single Use
  • Reagent
  • Professional Testing
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (15)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No