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HidraWear

by HidraMed Solutions Limited 20 variants

Ref GBB001-01

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number05391535510283 UDI-DI Date20 Dec 2022ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number539153551GBB001-016P Basic UDI-DI 05391535510283UDI-DIDate9 Nov 2021RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Non-adhesive device retention bandage
Device Name
HidraWear BB Women’s Briefs Small
Model / Reference
GBB001-01
Primary DI / UDI-DI
05391535510283
Basic UDI-DI
539153551GBB001-016P
FDA Product Code
MDR
EMDN Code
M0303010101 Elastic fixing bandages, non-adhesive, extensible in one direction
GMDN Term
Non-adhesive device retention bandage
Device Class
Class I
Regulation Number
880.5160
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
IE-MF-000000089

Other devices from Hidramed Solutions Limited

See all devices from Hidramed Solutions Limited →

Properties

  • Single Use
  • Prescription Use
  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (16)

  • 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
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No