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Multiple Tumor Marker Quality Control
EUDAMEDClass IVD General (EU MDR)
Ref QB1200Model Level Ⅰ:2.0mL×4
Identity
- Trade Name
- Multiple Tumor Marker Quality Control EUDAMED
- Device Name
- Multiple Tumor Marker Quality Control EUDAMED
- Model / Reference
- Level Ⅰ:2.0mL×4 EUDAMEDQB1200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942028500930 EUDAMED
- Basic UDI-DI
- B-06942028500930 EUDAMED
- EMDN Code
- W01021521 MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS 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
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
Multiple Tumor Marker Quality Control by Sichuan Orienter 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-06942028500930 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Sichuan Orienter Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000003026
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 84894d93-0e47-43ec-b917-c9c76677f5a7 61 fields · synced Jun 19, 2026