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Glutamate Dehydrogenase Reagent Kit（the Improved Dgkc Method）

EUDAMED

Class IVD General (EU MDR)

Ref 3005688Model R1: 4x50mL, R2: 2x25mLRef 3000555Model R1: 4x50mL, R2: 1x50mLRef 3021580

by Dirui Industrial Co., Ltd

Identity

Trade Name
GLUTAMATE DEHYDROGENASE REAGENT KIT（THE IMPROVED DGKC METHOD） EUDAMED
Device Name
GLUTAMATE DEHYDROGENASE REAGENT KIT（THE IMPROVED DGKC METHOD） EUDAMED
Model / Reference
R1: 4x50mL, R2: 2x25mL EUDAMED
3005688 EUDAMED
R1: 4x50mL, R2: 1x50mL EUDAMED
3000555 EUDAMED
3021580 EUDAMED

Identifiers

Primary DI / UDI-DI
06942202258893 EUDAMED
06942202246463 EUDAMED
06925794592484 EUDAMED
Basic UDI-DI
B-06942202258893 EUDAMED
B-06942202246463 EUDAMED
B-06925794592484 EUDAMED
EMDN Code
W01010117 GLUTAMATE 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

Glutamate Dehydrogenase Reagent Kit（the Improved 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 24808e21-11c1-471a-b92f-0bdbcb254bed 61 fields · synced Jul 28, 2026
  • EUDAMED f0378ee2-4151-4166-9a27-aa331d0efa10 61 fields · synced May 16, 2026
  • EUDAMED 6b015c0a-34ae-440f-a2c8-423b09150abb 61 fields · synced May 18, 2026