Identity
- Trade Name
- SOLOASSIST IIS EUDAMED
- Device Name
- SOLOASSIST II EUDAMED
- Model / Reference
- 182220 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260463842203 EUDAMED
- Basic UDI-DI
- 4260463840018T EUDAMED
- EMDN Code
- Z1202018001 ROBOTIC ARMS FOR VIDEOENDOSCOPY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Soloassist Iis by Aktormed GmbH — 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 | 4260463840018T | Class I | Active |
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Manufacturer
- Manufacturer
- AKTORmed GmbH
- EUDAMED SRN
- DE-MF-000006136
Sources (1)
- EUDAMED 2af82c05-d644-401c-8064-f67c632c7f58 61 fields · synced Jul 12, 2026