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SternMed GmbH
EUDAMEDClass IIa (EU MDR)
Ref 1160160Model Marcom 0.35T / Marcom 0.5T / Marcom 1.5TRef 1160140Ref 1001060Model Sonos 10 / Sonos 12Ref 3101150Model Lumax 25 / Lumax 15 / Lumax 5 / Lumax 3/ Lumax 3M / Lumax 1MRef 3100103Ref 3001002Model Onex 101 / Onex 102 / Onex 201 / Onex 202 / Onex 203Ref 5201000-6Model Pump Docking Station PDS-4Ref 3001003
Identity
- Trade Name
- SternMed GmbH EUDAMED
- Device Name
- MRI System EUDAMEDDiagnostic Ultrasound System EUDAMEDOperating Light EUDAMEDOperating Table EUDAMEDPump Docking Station EUDAMED
- Model / Reference
- Marcom 0.35T / Marcom 0.5T / Marcom 1.5T EUDAMED1160160 EUDAMED1160140 EUDAMEDSonos 10 / Sonos 12 EUDAMED1001060 EUDAMEDLumax 25 / Lumax 15 / Lumax 5 / Lumax 3/ Lumax 3M / Lumax 1M EUDAMED3101150 EUDAMED3100103 EUDAMEDOnex 101 / Onex 102 / Onex 201 / Onex 202 / Onex 203 EUDAMED3001002 EUDAMEDPump Docking Station PDS-4 EUDAMED5201000-6 EUDAMED3001003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04251730800309 EUDAMED04251730800293 EUDAMED04251730800408 EUDAMED04251730800040 EUDAMED04251730810421 EUDAMED04251730800484 EUDAMED04251730810285 EUDAMED04251730800491 EUDAMED
- Basic UDI-DI
- 42517308007L8 EUDAMED42517308010KV EUDAMED42517308015L7 EUDAMED42517308014L5 EUDAMED42517308174U EUDAMED
- Direct Marketing DI
- 04251730800309 EUDAMED04251730800293 EUDAMED04251730800408 EUDAMED04251730800040 EUDAMED04251730810421 EUDAMED04251730800484 EUDAMED04251730810285 EUDAMED04251730800491 EUDAMED
- EMDN Code
- Z11059099 VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS – OTHER EUDAMEDZ11040104 MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.) EUDAMEDZ129004 LIGHT SOURCES EUDAMEDZ12010701 FIXED SCIALYTIC LAMPS EUDAMEDZ12011202 OPERATING TABLES EUDAMEDZ12030399 INFUSION INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass I 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
EUDAMEDEUDAMED
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 (8)
- EUDAMED 88003b40-6d26-4e09-a2c2-b8ab63dfe0ce 61 fields · synced Aug 3, 2026
- EUDAMED d0a5c435-96a3-4aa7-813e-05a3a231e4e1 61 fields · synced May 17, 2026
- EUDAMED 5975d0f1-b641-4fe6-9b78-42e54fd29160 61 fields · synced May 17, 2026
- EUDAMED bd77ddc0-98a4-435a-acc1-9e0aea979afc 61 fields · synced May 18, 2026
- EUDAMED a6bc7cd7-0a45-4769-a17b-6154098b0fbe 61 fields · synced May 18, 2026
- EUDAMED c8396b65-fd6d-4049-907b-70255cd7ea51 61 fields · synced May 18, 2026
- EUDAMED 4ed5b6bb-6eea-4410-b409-196180fa0f04 61 fields · synced May 19, 2026
- EUDAMED ad436f6d-811a-4ae6-ab07-f542fbec2084 61 fields · synced May 19, 2026