Identity
- Trade Name
- Dansac EUDAMED
- Device Name
- 2-Piece Ostomy Skin Barrier, GX EUDAMED
- Model / Reference
- 1743-30 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05709817519013 EUDAMED
- Basic UDI-DI
- 5709817D02P065S00676K EUDAMED
- Unit of Use DI
- 25709817519017 EUDAMED
- EMDN Code
- A1002010401 UNIVERSAL PLATES FOR ABDOMINAL STOMA (COLO-, ILEO-, UROSTOMY) WITH NON-INTROFLEX STOMA EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark 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
Dansac by Dansac A/S — 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 | 5709817D02P065S00676K | Class I | Active |
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Manufacturer
- Manufacturer
- Dansac A/S
- EUDAMED SRN
- DK-MF-000001514
Sources (1)
- EUDAMED d50d7c9c-9370-4f58-aef3-1812b4833761 61 fields · synced Jun 19, 2026