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Teleflex IPN000982

by Teleflex Incorporated

Ref SMSL50203

Teleflex IPN000982 (SMSL50203) 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-14026704713728) and listed in FDA GUDID since 31 Dec 2020 (UDI-DI 14026704713728), 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-14026704713728 Basic UDI-DI 14026704713728UDI-DIDate23 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number14026704713728 UDI-DI Date31 Dec 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-14026704713728 registered 23 Jul 2026 Active
  • FDA GUDID UDI-DI 14026704713728 listed 31 Dec 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 14026704713728
  2. Registered EUDAMED B-14026704713728

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  • Withdrawn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 Wh Br 5 Kac-25 1N 24" Niceloop EUDAMED
Teleflex GUDID
Generic name
Polyester suture, bioabsorbable, multifilament, non-antimicrobial
Model / Ref / Catalog
SMSL50203, IPN000982
Primary DI / UDI-DI
14026704713728
Basic UDI-DI
B-14026704713728
FDA product code
GAT
EMDN code
H010201020201 Polyester multifilament with needle for open surgery
GMDN term
Polyester suture, 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
SMSL50203
GUDID
IPN000982
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, bioabsorbable, multifilament, non-antimicrobial

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
Other properties (20, all answered No)