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none Z38

by Zhejiang Mateside Medical Devices Technology Co., Ltd

Ref Z38Model Z11、Z12、Z13、Z14、Z15、Z16、Z17、Z18、Z19、Z21、Z22、Z23、Z25、Z26、Z27 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06975960550794 UDI-DI Date7 Oct 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697596055R01UH Basic UDI-DI 06975960550794UDI-DIDate3 Apr 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  • Withdrawn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
none
Generic Name
Handgrip disability-assistive walker, non-powered, foldable
Device Name
Rollator
Model / Reference
Z38, Z11、Z12、Z13、Z14、Z15、Z16、Z17、Z18、Z19、Z21、Z22、Z23、Z25、Z26、Z27 etc
Primary DI / UDI-DI
06975960550794
Basic UDI-DI
697596055R01UH
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
GUDID distribution status
In Commercial Distribution

Other devices from Zhejiang Mateside Medical Devices Technology Co., Ltd

See all devices from Zhejiang Mateside Medical Devices Technology Co., Ltd →

Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (21)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No