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Α-Hydroxybutyric Dehydrogenase Reagent Kit（dgkc Method）

EUDAMED

Class IVD General (EU MDR)

Ref 3000801Model R1: 4x50mL, R2: 1x50mLRef 3003066Model R1: 2x60mL, R2: 2x15mLRef 3021599

by Dirui Industrial Co., Ltd

Identity

Trade Name
α-HYDROXYBUTYRIC DEHYDROGENASE REAGENT KIT（DGKC METHOD） EUDAMED
Device Name
α-HYDROXYBUTYRIC DEHYDROGENASE REAGENT KIT（DGKC METHOD） EUDAMED
Model / Reference
R1: 4x50mL, R2: 1x50mL EUDAMED
3000801 EUDAMED
R1: 2x60mL, R2: 2x15mL EUDAMED
3003066 EUDAMED
3021599 EUDAMED

Identifiers

Primary DI / UDI-DI
06942202246975 EUDAMED
06942202260605 EUDAMED
06925794592071 EUDAMED
Basic UDI-DI
B-06942202246975 EUDAMED
B-06942202260605 EUDAMED
B-06925794592071 EUDAMED
EMDN Code
W01010118 HYDROXYBUTYRATE DEHYDROGENASE EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Austria 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-Hydroxybutyric Dehydrogenase Reagent Kit（dgkc Method） by Dirui Industrial Co., Ltd — Class IVD General — IVDD — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Dirui Industrial Co., Ltd
EUDAMED SRN
CN-MF-000001891
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (3)

  • EUDAMED 0c4ede95-f5ac-4da7-ae14-bc78342cbd59 61 fields · synced Jul 23, 2026
  • EUDAMED b52b09d1-8e52-41c5-8f32-f515758d2ff5 61 fields · synced May 18, 2026
  • EUDAMED b040ae92-5740-4298-a7f6-b9180c08252e 61 fields · synced Jul 23, 2026