Identity
- Trade Name
- STERILE SET IIS PU / 10 ea. EUDAMED
- Device Name
- STERILE SET IIS EUDAMED
- Model / Reference
- 242704 EUDAMED192289 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260463847048 EUDAMED04260463842890 EUDAMED
- Basic UDI-DI
- 4260463840128Y EUDAMED
- EMDN Code
- Z1202018099 REMOTE CONTROL ROBOT-ASSISTED ENDOSCOPIC SURGERY INSTRUMENTS - HARDWARE ACCESSORIES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Medical Purpose
- Sterile components for SOLOASSIST. The STERILE COVER is for sterile single-use covering of the SOLOASSIST. The ENDOSCOPE HOLDER is for sterile single-use holding of an endoscopic camera. EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Category: Robotic surgical arm system
STERILE SET IIS PU / 10 ea. by Aktormed GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 4260463840128Y | Class I | Active |
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Manufacturer
- Manufacturer
- AKTORmed GmbH
- EUDAMED SRN
- DE-PR-000053838
Sources (2)
- EUDAMED 2a893862-add2-4b8f-9acd-258903f89781 61 fields · synced Jul 18, 2026
- EUDAMED a69a7690-9f55-456a-947b-ecf4907ba64d 61 fields · synced May 17, 2026