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Urine Bag

by Changshushi Boyi Medical Devices Co., Ltd.

Ref BY-UB-DB-1000mlModel 350ml,400ml,500ml,600ml,750ml,800ml,900ml,1000ml,1500ml,2000ml,2500ml,3000ml,4000ml,5000ml

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 linked in EUDAMED

A group certificate may exist

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 Number697378343UB5V Basic UDI-DI 06973783431023UDI-DIDate27 May 2026RegisteredStatusActive EUDAMED: not on the EU market

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
350ml, 400ml, 500ml, 600ml, 750ml, 800ml, 900ml, 1000ml, 1500ml, 2000ml, 2500ml, 3000ml, 4000ml, 5000ml, BY-UB-DB-1000ml
Primary DI / UDI-DI
06973783431023
Basic UDI-DI
697378343UB5V
Direct Marketing DI
06973783431023
EMDN Code
A06030301 Urine collection bags
Device Class
Class I

Manufacturer details

EUDAMED SRN
CN-MF-000042836
Authorised representative
MedPath GmbH DE-AR-000000087

Properties

  • Sterile
  • Measuring Function

Other properties (11)

  • 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
  • Incorporates Medicinal Product: No