Identity
- Device Name
- Dilator, Dilatator EUDAMED
- Model / Reference
- 220-145 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049113048857 EUDAMED
- Basic UDI-DI
- 404911317401R00200100135 EUDAMED
- Direct Marketing DI
- 04049113048857 EUDAMED
- EMDN Code
- L040999 ABDOMINAL SURGERY DILATORS AND SPREADERS, 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
Dilator, Dilatator 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 | 404911317401R00200100135 | Class I | Active |
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Manufacturer
- Manufacturer
- ELCON Medical Instruments GmbH
- EUDAMED SRN
- DE-MF-000005908
Sources (1)
- EUDAMED f0a79084-e829-4c53-853e-b0f1809c2517 61 fields · synced Aug 1, 2026