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Rollator

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

Ref BR0006-7Model 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 Number06977176610743 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 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
Bradacare
Generic Name
Handgrip disability-assistive walker, non-powered, foldable
Device Name
Rollator
Model / Reference
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, BR0006-7
Primary DI / UDI-DI
06977176610743
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

Manufacturer details

EUDAMED SRN
CN-MF-000042118
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Bradacare (XiaMen) Health Technology Co., LTD

See all devices from Bradacare (XiaMen) Health Technology Co., LTD →

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)

  • EUDAMED b78a8878-ea7f-4d56-bb33-f622bcf4fee0 61 fields · synced 22 Oct 2026
  • FDA UDI 03e20bcd-46cc-4d2b-ba2e-efb6f20c8aa1 32 fields · synced 22 Oct 2026