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Weck IPN917215

by Teleflex Incorporated

Ref 525980

Weck IPN917215 (525980) is a device classified as Class IIa in the EU and Class I in the US made by Teleflex Incorporated, registered in EUDAMED on 23 Jul 2026 (Basic UDI-DI 08019020000000000000030JZ) and listed in FDA GUDID since 9 Jul 2024 (UDI-DI 14026704736314), 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 Number08019020000000000000030JZ Basic UDI-DI 14026704736314UDI-DIDate23 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number14026704736314 UDI-DI Date9 Jul 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08019020000000000000030JZ registered 23 Jul 2026 Active
  • FDA GUDID UDI-DI 14026704736314 listed 9 Jul 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 14026704736314
  2. Registered EUDAMED 08019020000000000000030JZ

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  • Withdrawn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
Weckstat Staple Extractor 12/Box EUDAMED
Weck GUDID
Generic name
Skin staple remover, single-use
Device name
Visistat Skin Stapler
Model / Ref / Catalog
525980, IPN917215
Primary DI / UDI-DI
14026704736314
Basic UDI-DI
08019020000000000000030JZ
FDA product code
QQS
EMDN code
H02010106 Metal surgical staple removers, single-use
GMDN term
Skin staple remover, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4740
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
Size
Length — 5.6 Inch

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
525980
GUDID
IPN917215
Device classEUDAMED
Class IIa
GUDID
Class I
ImplantableEUDAMED
Yes
GUDID
No

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: Skin staple remover, single-use

Similar devices in this category

Other devices filed under METAL SURGICAL STAPLE REMOVERS, SINGLE-USE.

Other devices from Teleflex Incorporated

  • Arrow IPNB00820 Open recall

    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
  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)