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Crutch

by Zhongshan Sunneo Medical Instruments Co., Ltd.

Ref DR9300001Model DR9300001、DR9300002、DR9300003、DR9300004、DR3100005、DR9300006、DR9300007、DR9300008、DR9300009、DR9300010、DR9300011、DR9300012、DR9300013、DR9300014、DR9300015、DR9300016、etc

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 linked in EUDAMED

A group certificate may exist

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 Number06978305011004 UDI-DI Date17 Nov 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697830501CrutchGU Basic UDI-DI 06978305011004UDI-DIDate26 Feb 2025RegisteredStatusActive

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

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  • Withdrawn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

Trade Name
Rollator
Generic Name
Handgrip disability-assistive walker, non-powered, non-foldable
Device Name
Crutch
Model / Reference
DR9300001、DR9300002、DR9300003、DR9300004、DR3100005、DR9300006、DR9300007、DR9300008、DR9300009、DR9300010、DR9300011、DR9300012、DR9300013、DR9300014、DR9300015、DR9300016、etc EUDAMED
DR9300001 EUDAMED
DR9222-A GUDID
Primary DI / UDI-DI
06978305011004
Basic UDI-DI
697830501CrutchGU
FDA Product Code
ITJ
EMDN Code
Y120303 White sticks for blind persons
GMDN Term
Handgrip disability-assistive walker, non-powered, non-foldable
Device Class
Class I
Regulation Number
890.3825
Market of Registration
Austria
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
CN-MF-000039352
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Zhongshan Sunneo Medical Instruments Co Ltd

See all devices from Zhongshan Sunneo Medical Instruments Co Ltd →

Properties

  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: 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
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No