Identity
- Device Name
- Retractor, Wundhaken EUDAMED
- Model / Reference
- 161-334 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049113028446 EUDAMED
- Basic UDI-DI
- 404911314101R002001001T6 EUDAMED
- Direct Marketing DI
- 04049113028446 EUDAMED
- EMDN Code
- L03140199 SPREADERS AND RETRACTORS FOR GENERAL SURGERY, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I 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
Retractor, Wundhaken by ELCON Medical Instruments 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 | 404911314101R002001001T6 | Class I | Active |
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Manufacturer
- Manufacturer
- ELCON Medical Instruments GmbH
- EUDAMED SRN
- DE-MF-000005908
Sources (1)
- EUDAMED 8fbd908e-a467-4140-a9d3-6458443fe71f 61 fields · synced Jul 9, 2026