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All Systems

by Silony Medical GmbH 9 variants

Part of a family of 11 devices: see the family page

Ref GI-3301

All Systems (GI-3301) is a Class I device made by Silony Medical GmbH, registered in EUDAMED on 20 May 2026 (Basic UDI-DI 4054896HANDLESW) and listed in FDA GUDID since 18 Sep 2026 (UDI-DI 04054896051109), 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
United StatesGUDID listing GUDID Number04054896051109 UDI-DI Date18 Sep 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number4054896HANDLESW Basic UDI-DI 04054896051109UDI-DIDate20 May 2026RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4054896HANDLESW registered 20 May 2026 Active
  • FDA GUDID UDI-DI 04054896051109 listed 18 Sep 2026 Listed

Timeline

2 dated events

  1. Registered EUDAMED 4054896HANDLESW
  2. Listed FDA GUDID 04054896051109

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  • Withdrawn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
All Systems EUDAMED
Handle GUDID
Generic name
Surgical instrument handle, non-torque-limiting
Model / Ref / Catalog
GI-3301
Primary DI / UDI-DI
04054896051109
Basic UDI-DI
4054896HANDLESW
FDA product code
LXH
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Surgical instrument handle, non-torque-limiting
Device class
Class I
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Manufacturer details

EUDAMED SRN
DE-MF-000006463

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER.

Other devices from Silony Medical GmbH

See all devices from Silony Medical GmbH →

Properties

  • Sterilise before use
  • Reusable
  • Premarket exempt
  • Lot / batch number
Other properties (21, all answered No)