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Tevdek IPN928576

by Teleflex Incorporated

Ref LSI-100002

Tevdek IPN928576 (LSI-100002) is a device classified as Class III in the EU and Class II in the US made by Teleflex Incorporated, registered in EUDAMED on 23 Jul 2026 (Basic UDI-DI B-14026704921482) and listed in FDA GUDID since 21 May 2024 (UDI-DI 14026704921482), 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-14026704921482 Basic UDI-DI 14026704921482UDI-DIDate23 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number14026704921482 UDI-DI Date21 May 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-14026704921482 registered 23 Jul 2026 Active
  • FDA GUDID UDI-DI 14026704921482 listed 21 May 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 14026704921482
  2. Registered EUDAMED B-14026704921482

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  • Withdrawn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
Tev Gn Br 2-0 Kt-3 2N 30" Lsi EUDAMED
Tevdek GUDID
Generic name
Polyester suture, non-bioabsorbable, multifilament, non-antimicrobial
Model / Ref / Catalog
LSI-100002, IPN928576
Primary DI / UDI-DI
14026704921482
Basic UDI-DI
B-14026704921482
FDA product code
GAT
EMDN code
H010201020201 Polyester multifilament with needle for open surgery
GMDN term
Polyester suture, non-bioabsorbable, multifilament, non-antimicrobial
Device class
Class III EUDAMED
Class II GUDID
Regulation number
878.5000
EU registration type
Legacy device (under a directive)
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
LSI-100002
GUDID
IPN928576
Device classEUDAMED
Class III
GUDID
Class II

Device class is stated on each registry's own scale: Class III in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Polyester suture, non-bioabsorbable, multifilament

Similar devices in this category

Other devices filed under POLYESTER MULTIFILAMENT WITH NEEDLE FOR OPEN SURGERY.

Other devices from Teleflex Incorporated

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    Class II

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    Class II

  • Arrow IPNB00822 Open recall

    Class II

  • Arrow IPNB00827 Open recall

    Class II

See all devices from Teleflex Incorporated →

Properties

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