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Chemiluminescent Immunoassay Controls for Tumor Marker Control
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref EIM4294106Model Tumor Marker Control
Identity
- Device Name
- Chemiluminescent Immunoassay Controls for Tumor Marker Control EUDAMED
- Model / Reference
- Tumor Marker Control EUDAMEDEIM4294106 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-EIM4294106J6 EUDAMED
- Basic UDI-DI
- B-EIM4294106J6 EUDAMED
- EMDN Code
- W0102152005 TUMOUR MARKER CONTROLS EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Chemiluminescent Immunoassay Controls for Tumor Marker Control by Maccura Biotechnology Co., Ltd. — Class IVD Annex II List B — 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-EIM4294106J6 | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- Maccura Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000014618
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED b99b2374-632d-42f5-b007-013f53434bbf 61 fields · synced Jun 18, 2026