Identity
- Trade Name
- RoboFIX EUDAMED
- Device Name
- RoboFIX EUDAMED
- Model / Reference
- 242791 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260463847918 EUDAMED
- Basic UDI-DI
- 42604638400899 EUDAMED
- EMDN Code
- Z12029099 VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI–INVASIVE SURGERY – OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
RoboFIX 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 | 42604638400899 | Class I | Active |
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Manufacturer
- Manufacturer
- AKTORmed GmbH
- EUDAMED SRN
- DE-MF-000006136
Sources (1)
- EUDAMED b798d0d2-838d-47bc-b683-1bec923351b5 61 fields · synced Jul 14, 2026