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Kheiron 01PC2010

by S.M.A.I.O

Ref 01PC2010

Kheiron 01PC2010 is a Class I device made by S.M.A.I.O, registered in EUDAMED on 16 Oct 2025 (Basic UDI-DI B-03701313002671) and listed in FDA GUDID since 18 Dec 2020 (UDI-DI 03701313002671), 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-03701313002671 Basic UDI-DI 03701313002671UDI-DIDate16 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number03701313002671 UDI-DI Date18 Dec 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-03701313002671 registered 16 Oct 2025 Active
  • FDA GUDID UDI-DI 03701313002671 listed 18 Dec 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03701313002671
  2. Registered EUDAMED B-03701313002671

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  • Withdrawn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 implant impactor, reusable
Device name
Impacteur pour connecteur axial
Model / Ref / Catalog
01PC2010
Primary DI / UDI-DI
03701313002671
Basic UDI-DI
B-03701313002671
FDA product code
HWA
EMDN code
L0999 Orthopaedic and traumatological surgery instruments, reusable - other
GMDN term
Orthopaedic implant impactor, reusable
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 implant impactor, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER.

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)