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Humeris Shoulder 911-0350

by Fx Solutions

Part of a family of 16 devices: see the family page

Ref 911-0350

Humeris Shoulder 911-0350 is a device classified as Class IIa in the EU and Class I in the US made by Fx Solutions, registered in EUDAMED on 19 Jun 2026 (Basic UDI-DI 37010373DRILLCD) and listed in FDA GUDID since 17 Sep 2018 (UDI-DI 03701037306772), 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 Number37010373DRILLCD Basic UDI-DI 03701037306772UDI-DIDate19 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03701037306772 UDI-DI Date17 Sep 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 37010373DRILLCD registered 19 Jun 2026 Active
  • FDA GUDID UDI-DI 03701037306772 listed 17 Sep 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03701037306772
  2. Registered EUDAMED 37010373DRILLCD

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  • Withdrawn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
Drill Bit
Model / Ref / Catalog
911-0350
Primary DI / UDI-DI
03701037306772
Basic UDI-DI
37010373DRILLCD
Direct marketing DI
03701037306772
FDA product code
HTW, LXH
EMDN code
L091102 Orthopaedic prostheses reamers and burs, reusable
GMDN term
Orthopaedic surgical procedure kit, non-medicated, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 5 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I 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 REAMERS AND BURS, 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)