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Weck IPN917216

by Teleflex Incorporated

Ref EFX002

Weck IPN917216 (EFX002) is a suturing unit (EU MDR Class IIa; FDA Class I; FDA product code HCF, Instrument, Ligature Passing and Knot Tying) made by Teleflex Incorporated, registered in EUDAMED on 12 May 2026 (Basic UDI-DI 08019020000000000000031K3) and listed in FDA GUDID since 16 Aug 2023 (UDI-DI 14026704736321), active as of 23 Oct 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08019020000000000000031K3 Basic UDI-DI 14026704736321UDI-DIDate12 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number14026704736321 UDI-DI Date16 Aug 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08019020000000000000031K3 registered 12 May 2026 Active
  • FDA GUDID UDI-DI 14026704736321 listed 16 Aug 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 14026704736321
  2. Registered EUDAMED 08019020000000000000031K3

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  • Withdrawn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
WECK EFx Shield Port Site Closure System EUDAMED
Weck GUDID
Generic name
Suturing unit, single-use
Device name
WECK® EFx Shield™ Fascial Closure System
Model / Ref / Catalog
EFX002, IPN917216
Primary DI / UDI-DI
14026704736321
Basic UDI-DI
08019020000000000000031K3
FDA product code
HCF
EMDN code
H9099 Suture devices - other
GMDN term
Suturing unit, 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
Size
Length — 7.9 Inch

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
EFX002
GUDID
IPN917216
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: Suturing unit, single-use

Similar devices in this category

Other devices filed under SUTURE DEVICES - OTHER.

Other devices from Teleflex Incorporated

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    Class II

  • Arrow IPNB00826 Open recall

    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
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)