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HidraWear Superabsorbent Dressing

by Winner Medical Co., Ltd.

Ref FB1001Model Foam lite dressing without border (Type II)

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 linked in EUDAMED

A group certificate may exist

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 Number694232707880GA Basic UDI-DI 16942327068589UDI-DIDate27 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
HidraWear Superabsorbent Dressing
Model / Reference
Foam lite dressing without border (Type II), FB1001
Primary DI / UDI-DI
16942327068589
Basic UDI-DI
694232707880GA
EMDN Code
M04040601 Polyurethane dressings, non-combined
Device Class
Class IIb
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000005692
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Related devices

Category: Negative-pressure wound therapy system foam dressing, non-antimicrobial

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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