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Hi-Fi IPN001165

by Teleflex Incorporated

Ref H6150T2

Hi-Fi IPN001165 (H6150T2) is a device classified as Class IIb in the EU and Class II in the US made by Teleflex Incorporated, registered in EUDAMED on 6 Jul 2026 (Basic UDI-DI B-44026704604102) and listed in FDA GUDID since 17 Jan 2019 (UDI-DI 44026704604102), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-44026704604102 Basic UDI-DI 44026704604102UDI-DIDate6 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number44026704604102 UDI-DI Date17 Jan 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-44026704604102 registered 6 Jul 2026 Active
  • FDA GUDID UDI-DI 44026704604102 listed 17 Jan 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 44026704604102
  2. Registered EUDAMED B-44026704604102

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  • Withdrawn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
Ffb Blu Br 2 Hc-5 2N 40"Linv EUDAMED
Hi-Fi GUDID
Generic name
Polyolefin/fluoropolymer suture, multifilament
Model / Ref / Catalog
H6150T2, IPN001165
Primary DI / UDI-DI
44026704604102
Basic UDI-DI
B-44026704604102
FDA product code
GAT
EMDN code
H0102010299 Synthetic nonabsorbable multifilament sutures - other
GMDN term
Polyolefin/fluoropolymer suture, multifilament
Device class
Class IIb 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
H6150T2
GUDID
IPN001165
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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, multifilament

Similar devices in this category

Other devices filed under SYNTHETIC NONABSORBABLE MULTIFILAMENT SUTURES - OTHER.

Other devices from Teleflex Incorporated

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  • 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)