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B80775

by Landanger

Ref B80775Model SELF-STATIC RETRACTING DEVICES, REUSABLE

B80775 is a Class I device made by Landanger, registered in EUDAMED on 15 Oct 2026 (Basic UDI-DI B-03661219013341) and listed in FDA GUDID since 15 Oct 2026 (UDI-DI 03661219013341), active as of 2 Nov 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 2 Nov 2026.

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-03661219013341 Basic UDI-DI 03661219013341UDI-DIDate15 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03661219013341 UDI-DI Date15 Oct 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-03661219013341 registered 15 Oct 2026 Active
  • FDA GUDID UDI-DI 03661219013341 listed 15 Oct 2026 Listed

Timeline

2 dated events

  1. Registered EUDAMED B-03661219013341
  2. Listed FDA GUDID 03661219013341

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  • Withdrawn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
Self-retaining surgical retractor, reusable
Model / reference
SELF-STATIC RETRACTING DEVICES, REUSABLE, B80775
Primary DI / UDI-DI
03661219013341
Basic UDI-DI
B-03661219013341
FDA product code
GAD
EMDN code
L03140101 Self-static spreaders, reusable
GMDN term
Self-retaining surgical retractor, 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

Manufacturer details

EUDAMED SRN
FR-MF-000000468

Similar devices in this category

Other devices filed under SELF-STATIC SPREADERS, REUSABLE.

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Properties

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