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Fx V135 911-2053

by Fx Solutions

Part of a family of 8 devices: see the family page

Ref 911-2053

Fx V135 911-2053 is a device classified as Class I in the EU and Class II in the US made by Fx Solutions, registered in EUDAMED on 23 Jun 2026 (Basic UDI-DI 37010373SMGDKMLHV) and listed in FDA GUDID since 20 Feb 2025 (UDI-DI 03701037321027), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number37010373SMGDKMLHV Basic UDI-DI 03701037321027UDI-DIDate23 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03701037321027 UDI-DI Date20 Feb 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 37010373SMGDKMLHV registered 23 Jun 2026 Active
  • FDA GUDID UDI-DI 03701037321027 listed 20 Feb 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03701037321027
  2. Registered EUDAMED 37010373SMGDKMLHV

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  • Withdrawn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
Fx V135
Generic name
Orthopaedic surgical procedure kit, non-medicated, reusable
Model / reference
911-2053
Primary DI / UDI-DI
03701037321027
Basic UDI-DI
37010373SMGDKMLHV
Direct marketing DI
03701037321027
FDA product code
PKC
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Orthopaedic surgical procedure kit, non-medicated, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3660
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Orthopaedic surgical procedure kit, non-medicated, reusable

Similar devices in this category

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

Other devices from Fx Solutions

See all devices from Fx Solutions →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)