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Urine Bag

by Well Lead Medical Co., Ltd. 4 variants

Part of a family of 6 devices: see the family page

Ref 15850101Model Exchange Bag

Urine Bag (15850101) is a Class I device made by Well Lead Medical Co., Ltd, registered in EUDAMED on 3 Aug 2026 (Basic UDI-DI 69449327FF04C01EY), active as of 22 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

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

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69449327FF04C01EY Basic UDI-DI 06925816694967UDI-DIDate3 Aug 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
Exchange Bag, 15850101
Primary DI / UDI-DI
06925816694967
Basic UDI-DI
69449327FF04C01EY
EMDN code
A06030301 Urine collection bags
Device class
Class I
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000006728
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Similar devices in this category

Other devices filed under URINE COLLECTION BAGS.

Other devices from Well Lead Medical Co., Ltd

See all devices from Well Lead Medical Co., Ltd →

Properties

  • Supplied sterile
Other properties (13, all answered No)