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Explor® 418078

by Biomet Orthopedics, Inc.

Ref 418078

Explor® 418078 is a Class I device made by Biomet Orthopedics, Inc., registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI 889024AD5Y7) and listed in FDA GUDID since 28 Jul 2017 (UDI-DI 00880304370920), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number889024AD5Y7 Basic UDI-DI 00880304370920UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00880304370920 UDI-DI Date28 Jul 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 889024AD5Y7 registered 30 Oct 2026 Active
  • FDA GUDID UDI-DI 00880304370920 listed 28 Jul 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00880304370920
  2. Registered EUDAMED 889024AD5Y7

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  • Withdrawn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
Explor®
Generic name
Surgical instrument handle, non-torque-limiting
Device name
Biomet Radial Head Handle
Model / Ref / Catalog
418078
Primary DI / UDI-DI
00880304370920
Basic UDI-DI
889024AD5Y7
Direct marketing DI
00880304370920
FDA product code
MDM
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Surgical instrument handle, non-torque-limiting
Device class
Class I
Regulation number
878.4800
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Surgical instrument handle, non-torque-limiting

Similar devices in this category

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

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (18, all answered No)