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Kheiron 01SH1020

by S.M.A.I.O

Ref 01SH1020

Kheiron 01SH1020 is a Class I device made by S.M.A.I.O, registered in EUDAMED on 20 Jul 2023 (Basic UDI-DI B-03701313004965) and listed in FDA GUDID since 15 Sep 2021 (UDI-DI 03701313004965), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-03701313004965 Basic UDI-DI 03701313004965UDI-DIDate20 Jul 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number03701313004965 UDI-DI Date15 Sep 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-03701313004965 registered 20 Jul 2023 Active
  • FDA GUDID UDI-DI 03701313004965 listed 15 Sep 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03701313004965
  2. Registered EUDAMED B-03701313004965

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  • Withdrawn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
Kheiron
Generic name
Orthopaedic osteotome
Device name
Rugine pour contre-crochet
Model / Ref / Catalog
01SH1020
Primary DI / UDI-DI
03701313004965
Basic UDI-DI
B-03701313004965
FDA product code
LXH
EMDN code
L090401 Orthopaedic surgery osteotomes, reusable
GMDN term
Orthopaedic osteotome
Device class
Class I
Regulation number
888.4540
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic osteotome

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGERY OSTEOTOMES, REUSABLE.

Other devices from S.M.A.I.O

See all devices from S.M.A.I.O →

Properties

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