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Ostomy Bag

by DongGuan Kangda Medical Technology Co., Ltd

Model One-piece Ostomy Bag, Two-piece Ostomy Bag

Ostomy Bag is a Class I device made by Dongguan Kangda Medical Technology Co., Ltd, registered in EUDAMED on 26 Oct 2022 (Basic UDI-DI 697582013OB001DQ) and listed in FDA GUDID since 17 Nov 2022 (UDI-DI 06975820130012), active as of 22 Oct 2026.

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

CE MDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06975820130012 UDI-DI Date17 Nov 2022ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697582013OB001DQ Basic UDI-DI 06975820130012UDI-DIDate26 Oct 2022RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 697582013OB001DQ registered 26 Oct 2022 Active
  • FDA GUDID UDI-DI 06975820130012 listed 17 Nov 2022 Listed

Certificates

0 certificates · EUDAMED

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

Timeline

2 dated events

  1. Registered EUDAMED 697582013OB001DQ
  2. Listed FDA GUDID 06975820130012

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  • Withdrawn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
Konweda
Generic name
One-piece intestinal ostomy bag, open-ended, single-use
Device name
Ostomy Bag
Model / reference
One-piece Ostomy Bag, Two-piece Ostomy Bag
Primary DI / UDI-DI
06975820130012
Basic UDI-DI
697582013OB001DQ
FDA product code
FON
EMDN code
A1001010101, A1001010102, A1001010201, A1001010202, A1001020101, A1001020102, A1001020201, A1001020202, A1001030101, A1001030102, A1001030201, A1001030202
GMDN term
One-piece intestinal ostomy bag, open-ended, single-use
Device class
Class I
Regulation number
876.5900
EU registration type
Standard device
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
One-piece Ostomy Bag, Two-piece Ostomy Bag
GUDID
One-piece Ostomy Bag

Manufacturer details

EUDAMED SRN
CN-MF-000025834
Authorised representative
Sungo Cert GmbH DE-AR-000010869

Similar devices in this category

Other devices filed under ONE-PIECE COLOSTOMY BAGS FOR NON-RETRACTED STOMA, FLAT.

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)