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Urine Bags

by Shanghai Sunshore Medical Instruments Co., Ltd

Ref Adult Urine BagModel Adult Urine Bag, Pediatric Urine bag, Luxury Urine bag ; 100ml, 200ml, 500ml, 750ml,1000ml ,1500ml ,2000ml; Pull-push Valve type , T-Tap/Cross Valve type ,Two Lines type

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number698023123UB0018H Basic UDI-DI 06980231232309UDI-DIDate6 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  • Withdrawn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
Urine Bags
Model / Reference
Adult Urine Bag, Pediatric Urine bag, Luxury Urine bag, 100ml, 200ml, 500ml, 750ml, 1000ml, 1500ml, 2000ml, Pull-push Valve type, T-Tap/Cross Valve type, Two Lines type
Primary DI / UDI-DI
06980231232309
Basic UDI-DI
698023123UB0018H
EMDN Code
A06030301 Urine collection bags
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000056183
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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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