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Lsss IN412

by Lockdown Medical Ltd

Ref IN412

Lsss IN412 is a device classified as Class IIa in the EU and Class I in the US made by Lockdown Medical Ltd, registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI 0506043360LOOPTENSIIA2E) and listed in FDA GUDID since 27 Feb 2019 (UDI-DI 05060433600715), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0506043360LOOPTENSIIA2E Basic UDI-DI 05060433600715UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05060433600715 UDI-DI Date27 Feb 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0506043360LOOPTENSIIA2E registered 4 Nov 2026 Active
  • FDA GUDID UDI-DI 05060433600715 listed 27 Feb 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05060433600715
  2. Registered EUDAMED 0506043360LOOPTENSIIA2E

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  • Withdrawn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
Lsss
Generic name
Orthopaedic graft tensioner, single-use
Device name
Loop Tensioner - Disposable
Model / Ref / Catalog
IN412
Primary DI / UDI-DI
05060433600715
Basic UDI-DI
0506043360LOOPTENSIIA2E
FDA product code
MDM
EMDN code
P091280 Osteosynthesis devices, devices for tendon and ligament synthesis - accessories
GMDN term
Orthopaedic graft tensioner, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4800
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

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: Orthopaedic graft tensioner, single-use

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS - ACCESSORIES.

Other devices from Lockdown Medical Ltd

See all devices from Lockdown Medical Ltd →

Properties

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