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Urine collection bag

by Changzhou Create Medical Instruments Co., Ltd. EUDAMED

Active European Union

Ref LX-3Model Economic urine collection bag (2000ml)：REF EC-1 Luxury urine collection bag(2000ml,2600ml,4000ml): REF: LX-1,LX-2,LX-3 Urine meter(2000+200ml,2000+500ml,2600+400ml,2600+500ml): REF: UM-1,UM-2,UM-3,UM-4

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number6975668521002FP Basic UDI-DIDate24 Dec 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
Urine collection bag
Model / Reference
Economic urine collection bag (2000ml)：REF EC-1 Luxury urine collection bag(2000ml, 2600ml, 4000ml): REF: LX-1, LX-2, LX-3 Urine meter(2000+200ml, 2000+500ml, 2600+400ml, 2600+500ml): REF: UM-1, UM-2, UM-3, UM-4, LX-3
Primary DI / UDI-DI
06975668522208
Basic UDI-DI
6975668521002FP
EMDN Code
A06030301 Urine collection bags
Device Class
Class I
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000027271
Authorised representative
phoenix Medtech GmbH DE-AR-000007996

Other devices from Changzhou Create Medical Instruments Co., Ltd.

See all devices from Changzhou Create Medical Instruments Co., Ltd. →

Properties

  • Sterile

Other properties (12)

  • 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