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Ostomy bag

by Yahui Medical Technology (Hubei) Co., Ltd.

Ref 8845Model 8845, 8855, 3011, 3022, 3033, 3055, 3065, 3075, 3085, 3095, 3010, 3025, 7021, 7125, 7128, 7130, 7160, 7170, 7080,or customized.

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number698026611OstomybagCN Basic UDI-DI 06980266110009UDI-DIDate1 Jul 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Ostomy bag
Model / Reference
8845, 8855, 3011, 3022, 3033, 3055, 3065, 3075, 3085, 3095, 3010, 3025, 7021, 7125, 7128, 7130, 7160, 7170, 7080, or customized.
Primary DI / UDI-DI
06980266110009
Basic UDI-DI
698026611OstomybagCN
EMDN Code
A1001010101 One-piece colostomy bags for non-retracted stoma, flat, w/o tissue cover
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000052852
Authorised representative
AION CIRCUITS, LDA PT-AR-000044689

Properties

Other properties (13)

  • 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