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Bradacare BR0005SK-1

by Bradacare (XiaMen) Health Technology Co., LTD China EUDAMEDGUDID

Ref BR0005SK-1Model BR0001/BR0001-1/BR0001-2/BR0001-3, BR0002/BR0002-1/BR0002-2/BR0002-3, BR0003/BR0003-1/BR0003-2/BR0003-3/BR0003-5 BR0005/BR0005-1/BR0005-2/BR0005-3/BR0005-5 BR0006/BR0006-1/BR0006-2/BR0006-3/BR0006-5

Product code ITJEMDN Y120612

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06977176610866 UDI-DIDate25 Aug 2026ListedStatusIn distribution
European UnionCE/MDR EUDAMED Number697717661BR001HC Basic UDI-DIDate24 May 2024RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 24 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 24 Oct 2026

Trade Name
Bradacare
Generic Name
Handgrip disability-assistive walker, non-powered, foldable
Device Name
Rollator
Model / Reference
BR0005SK-1, BR0001/BR0001-1/BR0001-2/BR0001-3, BR0002/BR0002-1/BR0002-2/BR0002-3, BR0003/BR0003-1/BR0003-2/BR0003-3/BR0003-5 BR0005/BR0005-1/BR0005-2/BR0005-3/BR0005-5 BR0006/BR0006-1/BR0006-2/BR0006-3/BR0006-5
Primary DI / UDI-DI
06977176610866
Basic UDI-DI
697717661BR001HC
FDA Product Code
ITJ
EMDN Code
Y120612 Walking trolleys
GMDN Term
Handgrip disability-assistive walker, non-powered, foldable
Device Class
Class I
Regulation Number
890.3825
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution

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Properties & raw data

Show properties, registry sources and raw records
  • Single Use
  • Premarket Exempt
  • Manufacturing Date
Other properties (21)
  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No

Sources (2)

  • FDA UDI 8f00cf64-0b0f-4f83-a843-4e6ca782f476 32 fields · synced 24 Oct 2026
  • EUDAMED 06977176610866|697717661BR001HC 61 fields · synced 24 Oct 2026