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J162877

by Landanger

Ref J162877Model HAND-HELD RETRACTING DEVICES, REUSABLE

J162877 is a Class I device made by Landanger, registered in EUDAMED on 16 Oct 2026 (Basic UDI-DI B-03661219432623) and listed in FDA GUDID since 22 Jan 2026 (UDI-DI 03661219432623), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-03661219432623 Basic UDI-DI 03661219432623UDI-DIDate16 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03661219432623 UDI-DI Date22 Jan 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-03661219432623 registered 16 Oct 2026 Active
  • FDA GUDID UDI-DI 03661219432623 listed 22 Jan 2026 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03661219432623
  2. Registered EUDAMED B-03661219432623

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  • Withdrawn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
Open-surgery dissector
Model / reference
HAND-HELD RETRACTING DEVICES, REUSABLE, J162877
Primary DI / UDI-DI
03661219432623
Basic UDI-DI
B-03661219432623
FDA product code
MDM
EMDN code
L031402 General surgery spatulas, reusable
GMDN term
Open-surgery dissector
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

Manufacturer details

EUDAMED SRN
FR-MF-000000468

Similar devices in this category

Other devices filed under GENERAL SURGERY SPATULAS, REUSABLE.

Other devices from Landanger

See all devices from Landanger →

Properties

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