Skip to content

EZX System 01

by Imedicom Co., Ltd.

Ref H-CAT-010-US-01Model EZX System 01

EZX System 01 is a device classified as Class IIa in the EU and Class I in the US made by Imedicom Co., Ltd., registered in EUDAMED on 4 Aug 2026 (Basic UDI-DI B-08800038044920) and listed in FDA GUDID since 29 Sep 2020 (UDI-DI 08800038044920), active as of 23 Oct 2026.

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

CE MDD

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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08800038044920 Basic UDI-DI 08800038044920UDI-DIDate4 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800038044920 UDI-DI Date29 Sep 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08800038044920 registered 4 Aug 2026 Active
  • FDA GUDID UDI-DI 08800038044920 listed 29 Sep 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08800038044920
  2. Registered EUDAMED B-08800038044920

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Ezx
Generic name
Sawing power tool attachment, sagittal
Device name
Powered surgical handpiece system
Model / reference
EZX System 01, H-CAT-010-US-01
Primary DI / UDI-DI
08800038044920
Basic UDI-DI
B-08800038044920
FDA product code
HWE
EMDN code
Z12130580 Motorised orthopaedic surgery system instruments - hardware accessories
GMDN term
Sawing power tool attachment, sagittal
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4820
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Sawing power tool attachment, sagittalBone/joint surgical power tool motor, electric

Similar devices in this category

Other devices filed under MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Imedicom Co., Ltd.

See all devices from Imedicom Co., Ltd. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (16, all answered No)