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Arrow Percutaneous Laparoscopic Cholangiography Set with Karlan Balloon Catheter

by Arrow International LLC (Subsidiary of Teleflex Incorporated)

Ref CS-01701

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

CE MDR

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08019020000000000000025K8 Basic UDI-DIDate12 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10801902170191 UDI-DIDate3 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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Arrow Percutaneous Laparoscopic Cholangiography Set with Karlan Balloon Catheter EUDAMED
Arrow GUDID
Generic Name
ERCP catheter, non-balloon, non-electrical, single-use
Device Name
Arrow Cholangiography Set
Model / Ref / Catalog
CS-01701, IPN917307
Primary DI / UDI-DI
10801902170191
Basic UDI-DI
08019020000000000000025K8
FDA Product Code
FGE
EMDN Code
G02060201 Open surgery cholangiography catheters
GMDN Term
ERCP catheter, non-balloon, non-electrical, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
876.5010
Market of Registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
CS-01701
GUDID
IPN917307
Device ClassEUDAMED
Class IIa
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
  • Contains Latex
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (16)

  • Implantable: No
  • Reusable: 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
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No