Identity
- Trade Name
- Dansac EUDAMED
- Device Name
- Irrigation Set with Adhesive Skin Barrier EUDAMED
- Model / Reference
- 900-35 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05709817195859 EUDAMED
- Basic UDI-DI
- 5709817D02P059S02057A EUDAMED
- EMDN Code
- A100301 ABDOMINAL OSTOMY IRRIGATION KITS 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 | 5709817D02P059S02057A | Class I | Active |
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Manufacturer
- Manufacturer
- Dansac A/S
- EUDAMED SRN
- DK-MF-000001514
Sources (1)
- EUDAMED 734522d3-fbb7-47c3-8853-874d39e18bbc 61 fields · synced Jun 18, 2026