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Renal Function Glucose and Lipid Lyophilized Kit 10
EUDAMEDClass IVD General (EU MDR)
Ref KF-002
Identity
- Trade Name
- Renal Function Glucose and Lipid Lyophilized Kit 10 EUDAMED
- Device Name
- Renal Function Glucose and Lipid Lyophilized Kit 10 EUDAMED
- Model / Reference
- KF-002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950996019323 EUDAMED
- Basic UDI-DI
- B-06950996019323 EUDAMED
- EMDN Code
- W01010404 MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R. EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Ireland 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
Renal Function Glucose and Lipid Lyophilized Kit 10 by Zhejiang Orient Gene Biotech 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-06950996019323 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Zhejiang Orient Gene Biotech Co., Ltd
- EUDAMED SRN
- CN-MF-000017965
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 4c8f2bc6-7349-4d60-b70f-a880eead8f8d 61 fields · synced Oct 6, 2026