Identity
- Trade Name
- Dansac EUDAMED
- Device Name
- 1-Piece Closed Ostomy Pouch, TRE, Convex EUDAMED
- Model / Reference
- MT031-59 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05709817602654 EUDAMED
- Basic UDI-DI
- 5709817D02P037S00935T EUDAMED
- Unit of Use DI
- 25709817602658 EUDAMED
- EMDN Code
- A1001010202 ONE-PIECE COLOSTOMY BAGS FOR RETRACTED STOMA, CONVEX, 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
Category: One-piece intestinal ostomy bag, closed-ended
Dansac by Dansac A/S — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as One-piece intestinal ostomy bag, closed-ended.
- SenSura Mio Concave — Coloplast A/S · Class I
- SenSura Mio Convex — Coloplast A/S · Class I
- Hollister — Hollister Incorporated · Class I
- SenSura Mio Convex — Coloplast A/S · Class I
- SenSura Mio Concave — Coloplast A/S · Class I
- Hollister — Hollister Incorporated · Class I
- SenSura Mio — Coloplast A/S · Class I
- SenSura Mio Convex — Coloplast A/S · Class I
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 | 5709817D02P037S00935T | Class I | Active |
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Manufacturer
- Manufacturer
- Dansac A/S
- EUDAMED SRN
- DK-MF-000001514
Sources (1)
- EUDAMED a920747d-a019-4099-a249-5bb6dd6d4986 61 fields · synced Jun 19, 2026