Identity
- Trade Name
- Sentimag Gen3 EUDAMED
- Device Name
- Sentimag EUDAMED
- Model / Reference
- SMS03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15060391210589 EUDAMED
- Basic UDI-DI
- 506039121SentimagDK EUDAMED
- Direct Marketing DI
- 15060391210589 EUDAMED
- EMDN Code
- A019012 BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sentimag Gen3 by Endomagnetics Ltd — 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 | 506039121SentimagDK | Class IIa | Active |
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Manufacturer
- Manufacturer
- Endomagnetics Ltd.
- EUDAMED SRN
- GB-MF-000007233
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 6af0a9f6-dd8e-47ba-87ce-4a69eb8ef198 61 fields · synced Jul 29, 2026