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SternMed GmbH
EUDAMEDClass IIa (EU MDR)
Ref 1160120Model Marcom 0.35T / Marcom 0.5T / Marcom 1.5T
Identity
- Trade Name
- SternMed GmbH EUDAMED
- Device Name
- MRI System EUDAMED
- Model / Reference
- Marcom 0.35T / Marcom 0.5T / Marcom 1.5T EUDAMED1160120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04251730800286 EUDAMED
- Basic UDI-DI
- 42517308007L8 EUDAMED
- Direct Marketing DI
- 04251730800286 EUDAMED
- EMDN Code
- Z11059099 VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS – OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
SternMed GmbH by SternMed GmbH — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 42517308007L8 | Class IIa | Active |
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Manufacturer
- Manufacturer
- SternMed GmbH
- EUDAMED SRN
- DE-MF-000015421
Sources (1)
- EUDAMED 0c14584f-4d3e-42fc-8db1-57834ece2cd4 61 fields · synced Jun 19, 2026