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Glutamate Dehydrogenase (GLDH) Test Kit (Enzymatic)
EUDAMEDClass IVD General (EU MDR)
Ref R1:100mL×1 R2:25mL×1（708）Ref R1:64mL×2 R2:16mL×2（701）
Identity
- Trade Name
- Glutamate Dehydrogenase (GLDH) Test Kit (Enzymatic) EUDAMED
- Device Name
- Glutamate Dehydrogenase (GLDH) Test Kit (Enzymatic) EUDAMED
- Model / Reference
- R1:100mL×1 R2:25mL×1（708） EUDAMEDR1:64mL×2 R2:16mL×2（701） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971674869177 EUDAMED06971674869146 EUDAMED
- Basic UDI-DI
- B-06971674869177 EUDAMEDB-06971674869146 EUDAMED
- EMDN Code
- W01010117 GLUTAMATE DEHYDROGENASE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
Glutamate Dehydrogenase (GLDH) Test Kit (Enzymatic) by Biobase Biodustry(Shandong) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06971674869177 | Class IVD General | Active |
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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 acf723d4-7f38-4501-9b5a-d0c96bde931e 61 fields · synced Oct 7, 2026
- EUDAMED 027a4d7f-85b3-4650-bca3-116c13f27168 61 fields · synced May 19, 2026