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Monoamine Oxidase Reagent Kit (Glutamate Dehydrogenase Assay)
EUDAMEDClass IVD General (EU MDR)
Ref 3011708Model R:1x25mL, Calibration sample: 1x1mL, Control: 1x1mLRef 3021581Ref 3012951Model R:1x25mLRef 3021632Model R:1×25mL
Identity
- Trade Name
- Monoamine Oxidase Reagent Kit (Glutamate Dehydrogenase Assay) EUDAMED
- Device Name
- Monoamine Oxidase Reagent Kit (Glutamate Dehydrogenase Assay) EUDAMED
- Model / Reference
- R:1x25mL, Calibration sample: 1x1mL, Control: 1x1mL EUDAMED3011708 EUDAMED3021581 EUDAMEDR:1x25mL EUDAMED3012951 EUDAMEDR:1×25mL EUDAMED3021632 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202246425 EUDAMED06925794592347 EUDAMED06942202258817 EUDAMED06925794592354 EUDAMED
- Basic UDI-DI
- B-06942202246425 EUDAMEDB-06925794592347 EUDAMEDB-06942202258817 EUDAMEDB-06925794592354 EUDAMED
- EMDN Code
- W01010199 ENZYMES - OTHER 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
Monoamine Oxidase Reagent Kit (Glutamate Dehydrogenase Assay) 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06942202246425 | Class IVD General | Active |
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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 (4)
- EUDAMED c69201c7-a560-4c09-bfd3-03766762d64f 61 fields · synced Jul 29, 2026
- EUDAMED 91543eda-457b-40fb-8ad2-dad23f41f795 61 fields · synced May 16, 2026
- EUDAMED ce4aae8b-849e-4e50-a1ca-2513da9a6de3 61 fields · synced May 18, 2026
- EUDAMED 0759daee-e146-4614-9dc3-986c3a294575 61 fields · synced May 18, 2026