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Devex 186428111

by Medos International Sàrl

Ref 186428111

Devex 186428111 is a device classified as Class IIb in the EU and Class II in the US made by Medos International Sàrl, registered in EUDAMED on 3 Nov 2026 (Basic UDI-DI B-CHMF000014268000063YF) and listed in FDA GUDID since 24 Sep 2015 (UDI-DI D-CHMF000014268000063YF), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-CHMF000014268000063YF Basic UDI-DI D-CHMF000014268000063YFUDI-DIDate3 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-CHMF000014268000063YF UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-CHMF000014268000063YF registered 3 Nov 2026 Active
  • FDA GUDID UDI-DI D-CHMF000014268000063YF listed 24 Sep 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID D-CHMF000014268000063YF
  2. Registered EUDAMED B-CHMF000014268000063YF

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  • Withdrawn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
Devex
Generic name
Metallic spinal interbody fusion cage
Model / Ref / Catalog
186428111
Primary DI / UDI-DI
D-CHMF000014268000063YF EUDAMED
10705034118963 GUDID
Basic UDI-DI
B-CHMF000014268000063YF
FDA product code
MQP
EMDN code
P09070101 Spinal cages
GMDN term
Metallic spinal interbody fusion cage
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3060
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
D-CHMF000014268000063YF
GUDID
10705034118963
Device classEUDAMED
Class IIb
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists D-CHMF000014268000063YF; FDA GUDID lists 10705034118963), so their flags are not compared. Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Similar devices in this category

Other devices filed under SPINAL CAGES.

Other devices from Medos International SARL

See all devices from Medos International SARL →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (20, all answered No)