Identity
- Trade Name
- Dansac EUDAMED
- Device Name
- 1-Piece Drainable Ostomy Pouch, GX EUDAMED
- Model / Reference
- 337-15 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05709817097009 EUDAMED
- Basic UDI-DI
- 5709817D02P039S00215U EUDAMED
- Unit of Use DI
- 05709817258875 EUDAMED
- EMDN Code
- A1001010102 ONE-PIECE COLOSTOMY BAGS FOR NON-RETRACTED STOMA, FLAT, WITH TISSUE COVER 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 | 5709817D02P039S00215U | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dansac A/S
- EUDAMED SRN
- DK-MF-000001514
Sources (1)
- EUDAMED 22e9d130-8b69-401a-ac14-0504be40138d 61 fields · synced Jun 19, 2026