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Disposable Urine Bag

by Sanmen Minsheng Medical Appliances Co., Ltd.

Ref 350mlModel 100ml；200ml；350ml; 500ml; 750ml; 1000ml; 1500ml; 2000ml; 3000ml; 500ml+1500ml; 200ml+2000ml; 300ml+2000ml; 400ml+2000ml; 500ml+2000ml; 600ml+2000ml; 400ml+2600ml; 500ml+2600ml

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697941945UrineBagDM Basic UDI-DI 06979419450154UDI-DIDate29 Dec 2025RegisteredStatusActive

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  • Withdrawn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
Disposable Urine Bag
Model / Reference
100ml；200ml；350ml, 500ml, 750ml, 1000ml, 1500ml, 2000ml, 3000ml, 500ml+1500ml, 200ml+2000ml, 300ml+2000ml, 400ml+2000ml, 500ml+2000ml, 600ml+2000ml, 400ml+2600ml, 500ml+2600ml, 350ml
Primary DI / UDI-DI
06979419450154
Basic UDI-DI
697941945UrineBagDM
EMDN Code
A06030301 Urine collection bags
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000051043
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Sanmen Minsheng Medical Appliances Co., Ltd.

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