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Teleflex IPN056766

by Teleflex Incorporated

Ref 833-234

Teleflex IPN056766 (833-234) is a device classified as Class III in the EU and Class II in the US made by Teleflex Incorporated, registered in EUDAMED on 22 Jul 2026 (Basic UDI-DI B-14026704735317) and listed in FDA GUDID since 1 Apr 2021 (UDI-DI 14026704735317), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-14026704735317 Basic UDI-DI 14026704735317UDI-DIDate22 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number14026704735317 UDI-DI Date1 Apr 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-14026704735317 registered 22 Jul 2026 Active
  • FDA GUDID UDI-DI 14026704735317 listed 1 Apr 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 14026704735317
  2. Registered EUDAMED B-14026704735317

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  • Withdrawn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
Blue Polypropylene Monofilament Size 0 two TC-43 Needles 48" BSC EUDAMED
Teleflex GUDID
Generic name
Polyolefin/fluoropolymer suture, monofilament
Device name
Dek Bl Mf 0 Tc-43 2N 48" Bsc
Model / Ref / Catalog
833-234, IPN056766
Primary DI / UDI-DI
14026704735317
Basic UDI-DI
B-14026704735317
FDA product code
GAW
EMDN code
H010201010401 Polypropylene monofilament with needle for open surgery
GMDN term
Polyolefin/fluoropolymer suture, monofilament
Device class
Class III EUDAMED
Class II GUDID
Regulation number
878.5010
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
833-234
GUDID
IPN056766
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: Polyolefin/fluoropolymer suture, monofilament

Similar devices in this category

Other devices filed under POLYPROPYLENE MONOFILAMENT WITH NEEDLE FOR OPEN SURGERY.

Other devices from Teleflex Incorporated

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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
  • Expiration date
Other properties (19, all answered No)