Identity
- Trade Name
- Silhouette EUDAMED
- Device Name
- Silhouette EUDAMED
- Model / Reference
- Silhouette EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09420071400041 EUDAMED
- Basic UDI-DI
- 094200714SilhouetteSW9U EUDAMED
- Direct Marketing DI
- 09420071400041 EUDAMED
- EMDN Code
- Z119007 IMAGE ACQUISITION MODULES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Northern Ireland 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
Silhouette by Aranz Medical Limited — Class I — 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 | 094200714SilhouetteSW9U | Class I | Active |
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Manufacturer
- Manufacturer
- ARANZ Medical Limited
- EUDAMED SRN
- NZ-MF-000027426
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED 54c01325-eb70-42bf-8c4c-0d72a80490bd 61 fields · synced May 23, 2026