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FiberOptix(R) IAB

by Arrow International LLC (Subsidiary of Teleflex Incorporated) 2 variants

Ref IAB-05830-LWS

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10801902172843 Basic UDI-DIDate4 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10801902172843 UDI-DIDate1 Aug 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
FiberOptix(R) IAB EUDAMED
Arrow GUDID
Generic Name
Intra-aortic balloon catheter
Model / Ref / Catalog
IAB-05830-LWS, IPN917531
Primary DI / UDI-DI
10801902172843, 10801902216776
Basic UDI-DI
B-10801902172843, B-10801902216776
FDA Product Code
DSP
EMDN Code
C019001 Aortic counterpulsation catheters
GMDN Term
Intra-aortic balloon catheter
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
870.3535
Market of Registration
Ireland
GUDID distribution status
In Commercial Distribution
Size
Catheter Gauge — 8.0 French

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
IAB-05830-LWS
GUDID
IPN917531
Device ClassEUDAMED
Class III
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000024256
Authorised representative
Teleflex Medical IE-AR-000015869

Other devices from Arrow International LLC (Subsidiary of Teleflex Incorporated)

See all devices from Arrow International LLC (Subsidiary of Teleflex Incorporated) →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Serial Number
  • Expiration Date

Other properties (17)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Manufacturing Date: No