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Landanger J162868

by Landanger

Ref J162868Model HAND-HELD RETRACTING DEVICES, REUSABLE

Landanger J162868 is a Class I device made by Landanger, registered in EUDAMED on 16 Oct 2026 (Basic UDI-DI B-03661219432531) and listed in FDA GUDID since 21 Feb 2024 (UDI-DI 03661219432531), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-03661219432531 Basic UDI-DI 03661219432531UDI-DIDate16 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03661219432531 UDI-DI Date21 Feb 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-03661219432531 registered 16 Oct 2026 Active
  • FDA GUDID UDI-DI 03661219432531 listed 21 Feb 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03661219432531
  2. Registered EUDAMED B-03661219432531

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  • Withdrawn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

Trade name
Landanger
Generic name
Suturing unit, reusable
Model / reference
J162868, HAND-HELD RETRACTING DEVICES, REUSABLE
Primary DI / UDI-DI
03661219432531
Basic UDI-DI
B-03661219432531
FDA product code
MDM
EMDN code
L03140104 Spreaders hooks, reusable
GMDN term
Suturing unit, reusable
Device class
Class I
Regulation number
878.4800
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Suturing unit, reusable

Similar devices in this category

Other devices filed under SPREADERS HOOKS, REUSABLE.

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Properties

  • Sterilise before use
  • Reusable
  • Premarket exempt
  • Lot / batch number
Other properties (21, all answered No)