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Biofoam 46640001

by Wright Medical Technology, Inc.

Ref 46640001Model 08858251007007T3

Biofoam 46640001 is a Class I device made by Wright Medical Technology, Inc., registered in EUDAMED on 24 Sep 2026 (Basic UDI-DI 08858251007007T3) and listed in FDA GUDID since 17 Sep 2016 (UDI-DI 00889797015165), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251007007T3 Basic UDI-DI 00889797015165UDI-DIDate24 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889797015165 UDI-DI Date17 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251007007T3 registered 24 Sep 2026 Active
  • FDA GUDID UDI-DI 00889797015165 listed 17 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00889797015165
  2. Registered EUDAMED 08858251007007T3

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  • Withdrawn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
Biofoam® EUDAMED
Biofoam GUDID
Generic name
Orthopaedic implant impactor, reusable
Device name
Biofoam Wedge Instrumentation - Impact Instrumentation - Class I - Reusable - Non-sterile
Model / Ref / Catalog
46640001, 08858251007007T3
Primary DI / UDI-DI
00889797015165
Basic UDI-DI
08858251007007T3
Direct marketing DI
00889797015165
FDA product code
HWA
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Orthopaedic implant impactor, reusable
Device class
Class I
Regulation number
888.4540
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: Orthopaedic implant impactor, reusable

Similar devices in this category

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

Other devices from Wright Medical Technology, Inc.

See all devices from Wright Medical Technology, 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)