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Total Bile Acid Reagent Kit (Enzymatic Cycling Method)
EUDAMEDClass B (EU MDR)
Ref /
Identity
- Device Name
- Total Bile Acid Reagent Kit (Enzymatic Cycling Method) EUDAMED
- Model / Reference
- / EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06935740733250 EUDAMED06935740739269 EUDAMED06935740740753 EUDAMED06935740711623 EUDAMED
- Basic UDI-DI
- 69357407ICAS000012AM EUDAMED
- EMDN Code
- W01010202 BILE ACIDS EUDAMED
Classification
- Device Class
- Class B 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
New Device
No
EUDAMED
Total Bile Acid Reagent Kit (Enzymatic Cycling Method) by URIT Medical Electronic Co., Ltd. — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 69357407ICAS000012AM | Class B | 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 (4)
- EUDAMED 1153414b-7bd4-4807-819f-815a236ffcb2 61 fields · synced Oct 6, 2026
- EUDAMED effaad8f-07e3-43f7-b70f-46f84a175971 61 fields · synced May 16, 2026
- EUDAMED 571c56e4-5686-46ce-a34d-aec91b92402a 61 fields · synced May 16, 2026
- EUDAMED 69bc398f-36f4-4c92-a592-afa194d28558 61 fields · synced May 17, 2026