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β-Hydroxybutyrate (β-Hb）Test Kit (β-Hydroxybutyrate Dehydrogenase Method)
EUDAMEDClass IVD General (EU MDR)
Ref "REF: U84082040M, U84089060M, U84085020M, U84011020M, U84020060M"
Identity
- Device Name
- β-Hydroxybutyrate (β-Hb）Test Kit (β-Hydroxybutyrate Dehydrogenase Method) EUDAMED
- Model / Reference
- "REF: U84082040M, U84089060M, U84085020M, U84011020M, U84020060M" EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-6-23A6 EUDAMED
- Basic UDI-DI
- B-6-23A6 EUDAMED
- EMDN Code
- W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER 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
Category: Nucleic acid extraction/isolation kit IVD
β-Hydroxybutyrate (β-Hb）Test Kit (β-Hydroxybutyrate Dehydrogenase Method) by URIT Medical Electronic Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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Also classified as Nucleic acid extraction/isolation kit IVD.
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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-6-23A6 | 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 a6579db1-7480-41bf-ae71-d2395523acc7-1 61 fields · synced Jul 19, 2026
- EUDAMED a6579db1-7480-41bf-ae71-d2395523acc7-2 61 fields · synced Jul 19, 2026