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Humeris Shoulder 911-1030

by Fx Solutions

Ref 911-1030

Humeris Shoulder 911-1030 is an orthopaedic surgical procedure kit (EU MDR Class I; FDA Class II) made by Fx Solutions, registered in EUDAMED on 22 Jun 2026 (Basic UDI-DI 37010373CLAMP9T) and listed in FDA GUDID since 26 Mar 2024 (UDI-DI 03701037319147), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number37010373CLAMP9T Basic UDI-DI 03701037319147UDI-DIDate22 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03701037319147 UDI-DI Date26 Mar 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 37010373CLAMP9T registered 22 Jun 2026 Active
  • FDA GUDID UDI-DI 03701037319147 listed 26 Mar 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03701037319147
  2. Registered EUDAMED 37010373CLAMP9T

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  • Withdrawn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
Humeris Shoulder
Generic name
Orthopaedic surgical procedure kit, non-medicated, reusable
Device name
Clamp
Model / Ref / Catalog
911-1030
Primary DI / UDI-DI
03701037319147
Basic UDI-DI
37010373CLAMP9T
Direct marketing DI
03701037319147
FDA product code
PHX, KWT, HSD
EMDN code
L091103 Orthopaedic prostheses forceps, reusable
GMDN term
Orthopaedic surgical procedure kit, non-medicated, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3660, 888.3650, 888.3690
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 PROSTHESES FORCEPS, REUSABLE.

Other devices from Fx Solutions

See all devices from Fx Solutions →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (20, all answered No)