Identity
- Trade Name
- Sentimag Gen2 EUDAMED
- Device Name
- Sentimag EUDAMED
- Model / Reference
- SMS02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15060391210084 EUDAMED
- Basic UDI-DI
- 506039121SentimagDK EUDAMED
- Direct Marketing DI
- 15060391210084 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 Gen2 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 4c1df5fd-c5cc-4175-acb3-49f9e23e6f67 61 fields · synced Jun 19, 2026