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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

Dansac — Class I MDR by Dansac A/S

MD Atlas
Dansac A/S

EUDAMED last updated this device on Apr 23, 2026

Dansac

5709817D02P043S010546

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Dansac A/S
UDI-DI code: 05709817604245
Reference / catalog number: 3493-37

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Manufacturer information

Organization name: Dansac A/S
SRN: DK-MF-000001514
Manufacturer status: Active

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Market distribution

Primary placement in Denmark; available across 1 country total.

Country	On market since	Until
DenmarkPrimary placement		Still on market

Device identification

Trade name: Dansac
UDI-DI code: 05709817604245
Basic UDI-DI: 5709817D02P043S010546
Reference / catalog number: 3493-37
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 10
Additional product description: 1-Piece Urostomy Pouch, TRE, Convex
Additional information URL: https://www.dansac.com/
Clinical sizes: 15–37 MU50

EMDN nomenclature code(s)

A1001030202ONE-PIECE UROSTOMY BAGS FOR RETRACTED STOMA, CONVEX, WITH TISSUE COVER

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

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