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Kheiron 01BS0111

by S.M.A.I.O

Ref 01BS0111

Kheiron 01BS0111 is a Class I device made by S.M.A.I.O, registered in EUDAMED on 13 Oct 2025 (Basic UDI-DI B-03701313001964) and listed in FDA GUDID since 18 Dec 2020 (UDI-DI 03701313001964), 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-03701313001964 Basic UDI-DI 03701313001964UDI-DIDate13 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number03701313001964 UDI-DI Date18 Dec 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-03701313001964 registered 13 Oct 2025 Active
  • FDA GUDID UDI-DI 03701313001964 listed 18 Dec 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03701313001964
  2. Registered EUDAMED B-03701313001964

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  • Withdrawn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
Surgical instrument/implant rack
Device name
Base pour instruments #1
Model / Ref / Catalog
01BS0111
Primary DI / UDI-DI
03701313001964
Basic UDI-DI
B-03701313001964
FDA product code
FSM
EMDN code
S010401 Trays, baskets, tubs for sterilisation and their components
GMDN term
Surgical instrument/implant rack
Device class
Class I
Regulation number
878.4800
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: Surgical instrument/implant rack

Similar devices in this category

Other devices filed under TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS.

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)