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Breathing Bag, 3L, Latex, with loop end, Black

by Winnomed Company Ltd.

Ref 64133Model Disposable Reservoir Bag - Latex/Latex-Free

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDR, withdrawn

Ended

Withdrawn

Date not published (CE MDR)

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number471989776641NL Basic UDI-DI 04719897760237UDI-DIDate1 Dec 2023RegisteredStatusWithdrawn No longer placed on the EU market

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  • Withdrawn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European Union — CE/MDR Withdrawn

Specification

EUDAMED

Device Name
Breathing Bag
Model / Reference
Disposable Reservoir Bag - Latex/Latex-Free, 64133
Primary DI / UDI-DI
04719897760237
Basic UDI-DI
471989776641NL
EMDN Code
R03020199 Ventilation balloons - other
Device Class
Class I

Manufacturer details

EUDAMED SRN
TW-MF-000037459
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

From the manufacturer

Manufacturer's product page: Silicone Breathing Bag

Properties

  • Contains Latex

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Reusable: 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