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Arrow IPN921160

by Teleflex Incorporated

Ref CL-07545

Arrow IPN921160 (CL-07545) is a device classified as Class IIa in the EU and Class II in the US made by Teleflex Incorporated, registered in EUDAMED on 6 Jul 2026 (Basic UDI-DI B-10801902200911) and listed in FDA GUDID since 9 Nov 2022 (UDI-DI 10801902200911), active as of 9 Nov 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 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10801902200911 Basic UDI-DI 10801902200911UDI-DIDate6 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10801902200911 UDI-DI Date9 Nov 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-10801902200911 registered 6 Jul 2026 Active
  • FDA GUDID UDI-DI 10801902200911 listed 9 Nov 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10801902200911
  2. Registered EUDAMED B-10801902200911

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  • Withdrawn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
Super Arrow-Flex(R) Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port and Radiopaque Tip Marker Band EUDAMED
Arrow GUDID
Generic name
Vascular catheter introduction set, nonimplantable
Device name
Cath Lab Sheath Intro Set
Model / Ref / Catalog
CL-07545, IPN921160
Primary DI / UDI-DI
10801902200911
Basic UDI-DI
B-10801902200911
FDA product code
DYB
EMDN code
C0502 Cardiovascular introducer sheaths, valved
GMDN term
Vascular catheter introduction set, nonimplantable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.1340
EU registration type
Legacy device (under a directive)
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
CL-07545
GUDID
IPN921160
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Vascular catheter introduction set, nonimplantable

Similar devices in this category

Other devices filed under CARDIOVASCULAR INTRODUCER SHEATHS, VALVED.

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