Skip to content

219392

by Medos International Sàrl

Ref 219392Model Tibial Guide System Instruments

219392 is a Class I device made by Medos International Sàrl, registered in EUDAMED on 21 May 2026 (Basic UDI-DI 0886705a00148KQ) and listed in FDA GUDID since 1 Sep 2015 (UDI-DI 10886705006212), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0886705a00148KQ Basic UDI-DI 10886705006212UDI-DIDate21 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10886705006212 UDI-DI Date1 Sep 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0886705a00148KQ registered 21 May 2026 Active
  • FDA GUDID UDI-DI 10886705006212 listed 1 Sep 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10886705006212
  2. Registered EUDAMED 0886705a00148KQ

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  • Withdrawn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
Tibial Guide Arm - Elbow Aimer
Generic name
Orthopaedic guidewire, reusable
Device name
Tibial Guide, Bullet, Rail, Arm, Elbow, Tip
Model / Ref / Catalog
219392, Tibial Guide System Instruments
Primary DI / UDI-DI
10886705006212
Basic UDI-DI
0886705a00148KQ
Direct marketing DI
10886705006212
FDA product code
FZX
EMDN code
Z12139099 Various orthopaedic and traumatology instruments - other
GMDN term
Orthopaedic guidewire, reusable
Device class
Class I
Regulation number
878.4800
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic guidewire, reusable

Similar devices

Also classified as Orthopaedic guidewire, reusable.

Similar devices in this category

Other devices filed under VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - OTHER.

Other devices from Medos International SARL

See all devices from Medos International SARL →

Properties

  • Sterilise before use
  • Reusable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Measuring function
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (18, all answered No)