Skip to content

SenSura Flex

by Coloplast A/S 8 variants

Ref 11314

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number57089322976068W Basic UDI-DI Date17 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05708932352314 UDI-DI Date2 Dec 2022ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Intestinal ostomy base plate, convex
Device Name
SenSura Flex ostomy baseplate convex
Model / Ref / Catalog
11314
Primary DI / UDI-DI
05708932352314 EUDAMED
05708932362160 EUDAMED
05708932356299 EUDAMED
05708932351492 EUDAMED
05708932384957 EUDAMED
05708932348973 EUDAMED
05708932360333 GUDID
Basic UDI-DI
57089322976068W
Unit of Use DI
05701780067188, 05708932963541, 05701780067218, 05701780067362, 05701780067270, 05701780067195
FDA Product Code
EXB
EMDN Code
A1002010402 Universal plates for abdominal stoma (colo-, ileo-, urostomy) with introflex stoma
GMDN Term
Intestinal ostomy base plate, convex
Device Class
Class I
Regulation Number
876.5900
EU market of registration
Norway
Germany
Denmark
Ireland
Netherlands
Liechtenstein
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe
Size
Lumen/Inner Diameter — 50 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
05708932352314
05708932362160
05708932356299
05708932351492
05708932384957
05708932348973
GUDID
05708932360333

Manufacturer details

EUDAMED SRN
DK-MF-000025526

Other devices from Coloplast A/S

See all devices from Coloplast A/S →

Properties

  • Single Use
  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No