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228143

by DePuy Mitek, Inc.

Ref 228143

228143 is a device classified as Class IIa in the EU and Class I in the US made by DePuy Mitek, Inc., registered in EUDAMED on 9 Oct 2026 (Basic UDI-DI B-USMF000045334000053TT) and listed in FDA GUDID since 1 Sep 2015 (UDI-DI D-USMF000045334000053TT), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-USMF000045334000053TT Basic UDI-DI D-USMF000045334000053TTUDI-DIDate9 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-USMF000045334000053TT UDI-DI Date1 Sep 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-USMF000045334000053TT registered 9 Oct 2026 Active
  • FDA GUDID UDI-DI D-USMF000045334000053TT listed 1 Sep 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID D-USMF000045334000053TT
  2. Registered EUDAMED B-USMF000045334000053TT

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic name
Suturing unit, single-use
Model / Ref / Catalog
228143
Primary DI / UDI-DI
D-USMF000045334000053TT EUDAMED
10886705010059 GUDID
Basic UDI-DI
B-USMF000045334000053TT
FDA product code
GEF
EMDN code
K030299 Arthroscopy surgical instruments, single use - other
GMDN term
Suturing unit, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4800
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
D-USMF000045334000053TT
GUDID
10886705010059
Device classEUDAMED
Class IIa
GUDID
Class I

The registries describe this device under different primary UDI-DIs (EUDAMED lists D-USMF000045334000053TT; FDA GUDID lists 10886705010059), so their flags are not compared. 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: Suturing unit, single-use

Similar devices in this category

Other devices filed under ARTHROSCOPY SURGICAL INSTRUMENTS, SINGLE USE - OTHER.

Other devices from DePuy Mitek, Inc.

See all devices from DePuy Mitek, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)