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

EUDAMEDFDA UDI

Class IVD General (EU MDR)

Ref R1:48mL×2 R2:12mL×2（716）

by Biobase Biodustry(Shandong) Co., Ltd.

Identity

Trade Name
α-Hydroxybutyrate Dehydrogenase (α-HBDH) Test Kit (DGKC) EUDAMED
BIOBASE FDA UDI
Generic Name
Alpha-hydroxybutyrate dehydrogenase IVD, reagent FDA UDI
Device Name
α-Hydroxybutyrate Dehydrogenase (α-HBDH) Test Kit (DGKC) EUDAMED
Model / Reference
R1:48mL×2 R2:12mL×2（716） EUDAMED
R1:48mL×2 R2:12mL×2 FDA UDI

Identifiers

Primary DI / UDI-DI
06971674863519 EUDAMEDFDA UDI
Basic UDI-DI
B-06971674863519 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 EUDAMED
Class 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

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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 1b20da00-72d3-43bb-ba2e-b80c8c26fcf4 61 fields · synced Jul 9, 2026
  • FDA UDI 258074aa-2990-4849-8921-d8c5a2248a42 32 fields · synced May 30, 2026