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Easiflex

by Coloplast A/S

Ref 14307

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number57089322976158X Basic UDI-DI Date12 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05708932163712 UDI-DI Date7 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  • Withdrawn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

Trade Name
Easiflex EUDAMED
Assura GUDID
Generic Name
Intestinal ostomy base plate, flat
Device Name
Easiflex ostomy baseplate
Model / Ref / Catalog
14307
Primary DI / UDI-DI
05708932163712 EUDAMED
05708932169202 EUDAMED
05708932675505 EUDAMED
05708932069281 EUDAMED
05708932223614 EUDAMED
05708932169493 EUDAMED
05708932218030 EUDAMED
05708932409131 EUDAMED
05708932177092 EUDAMED
05708932191302 EUDAMED
00762123046906 GUDID
Basic UDI-DI
57089322976158X
Unit of Use DI
05701780111515, 05701780111683, 05701780111553, 05701780111638, 05701780111577, 05708932960946, 05708932671651, 05701780111775, 05701780111652, 05701780111706
FDA Product Code
EXB
EMDN Code
A1002010401 Universal plates for abdominal stoma (colo-, ileo-, urostomy) with non-introflex stoma
GMDN Term
Intestinal ostomy base plate, flat
Device Class
Class I
Regulation Number
876.5900
EU market of registration
Denmark
Netherlands
Czechia
Slovakia
Liechtenstein
Germany
Belgium
Italy
Ireland
Finland
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
05708932163712
05708932169202
05708932675505
05708932069281
05708932223614
05708932169493
05708932218030
05708932409131
05708932177092
05708932191302
GUDID
00762123046906

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