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α-Hydroxybutyrate Dehydrogenase Reagent Kit (α-ketobutyric Acid Substrate Metho…
EUDAMEDClass IVD General (EU MDR)
Ref "REF: U84485040M, U84489060M, U84485020M, U84422060M"
Identity
- Device Name
- α-Hydroxybutyrate Dehydrogenase Reagent Kit (α-ketobutyric Acid Substrate Method) EUDAMED
- Model / Reference
- "REF: U84485040M, U84489060M, U84485020M, U84422060M" EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-6-777 EUDAMED
- Basic UDI-DI
- B-6-777 EUDAMED
- EMDN Code
- W01010118 HYDROXYBUTYRATE DEHYDROGENASE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain 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-Hydroxybutyrate Dehydrogenase Reagent Kit (α-ketobutyric Acid Substrate Metho… by URIT Medical Electronic Co., Ltd. — Class IVD General — IVDD — listed in…
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-6-777 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- URIT Medical Electronic Co., Ltd.
- EUDAMED SRN
- CN-MF-000011840
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 8b0c1379-0f63-413b-8658-55c996a57308-1 61 fields · synced Jul 13, 2026
- EUDAMED 8b0c1379-0f63-413b-8658-55c996a57308-2 61 fields · synced Jul 13, 2026