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Bile Acids Kit(LC-MS/MS)
EUDAMEDClass IVD General (EU MDR)
Ref ZY3078PModel 100 T
Identity
- Trade Name
- Bile Acids Kit(LC-MS/MS) EUDAMED
- Device Name
- Bile Acids Kit(LC-MS/MS) EUDAMED
- Model / Reference
- 100 T EUDAMEDZY3078P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936595780666 EUDAMED
- Basic UDI-DI
- B-06936595780666 EUDAMED
- EMDN Code
- W01010202 BILE ACIDS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Türkiye 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Bile Acids Kit(LC-MS/MS) by Medicalsystem Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06936595780666 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- MedicalSystem Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010246
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED b9e770b1-83c4-4d35-9e0a-2a8a7dd2066f 61 fields · synced Jul 14, 2026