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ZeroG-Passive System

by Aretech, LLC

Ref ZGP-110

ZeroG-Passive System (ZGP-110) is a Class I device made by Aretech, LLC, registered in EUDAMED on 17 Aug 2023 (Basic UDI-DI 08500188360675) and listed in FDA GUDID since 24 Sep 2021 (UDI-DI 00850018836067), active as of 22 Oct 2026.

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

CE MDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08500188360675 Basic UDI-DI 00850018836067UDI-DIDate17 Aug 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00850018836067 UDI-DI Date24 Sep 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08500188360675 registered 17 Aug 2023 Active
  • FDA GUDID UDI-DI 00850018836067 listed 24 Sep 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00850018836067
  2. Registered EUDAMED 08500188360675

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  • Withdrawn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
Gait rehabilitation frame, manual
Model / reference
ZGP-110
Primary DI / UDI-DI
00850018836067
Basic UDI-DI
08500188360675
FDA product code
IKX
EMDN code
Z120602 Physiotherapy equipment
GMDN term
Gait rehabilitation frame, manual
Device class
Class I
Regulation number
890.5050
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
US-MF-000008500
Authorised representative
MedEnvoy Global BV NL-AR-000024028

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Properties

  • Premarket exempt
  • Serial number
Other properties (23, all answered No)