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Cardiopulmonary Markers Controls
EUDAMEDClass IVD General (EU MDR)
Ref MCL01101E
Identity
- Trade Name
- Cardiopulmonary Markers Controls EUDAMED
- Device Name
- Cardiopulmonary Markers Controls EUDAMED
- Model / Reference
- MCL01101E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06926802603413 EUDAMED
- Basic UDI-DI
- B-06926802603413 EUDAMED
- EMDN Code
- W01021521 MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
Cardiopulmonary Markers Controls by Medcaptain Medical Technology 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-06926802603413 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Medcaptain Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005925
- Authorised Representative
- R Sight B.V. NL-AR-000010445
Sources (1)
- EUDAMED 50a12213-4ef7-4845-a172-f8c33e3cfb57 61 fields · synced Jun 18, 2026