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Infiniti 538494P

by Cordis Corporation

Ref 538-494P

Infiniti 538494P is a device classified as Class III in the EU and Class II in the US made by Cordis Corporation, registered in EUDAMED on 24 Sep 2026 (Basic UDI-DI B-10705032015004) and listed in FDA GUDID since 1 Aug 2016 (UDI-DI 10705032015004), active as of 23 Oct 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10705032015004 Basic UDI-DI 10705032015004UDI-DIDate24 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10705032015004 UDI-DI Date1 Aug 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-10705032015004 registered 24 Sep 2026 Active
  • FDA GUDID UDI-DI 10705032015004 listed 1 Aug 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10705032015004
  2. Registered EUDAMED B-10705032015004

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  • Withdrawn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
PRIMOPAC™ Diagnostic Catheterization Sets EUDAMED
Infiniti GUDID
Generic name
Angiographic catheter, single-use
Model / Ref / Catalog
538-494P EUDAMED
538494P GUDID
Primary DI / UDI-DI
10705032015004
Basic UDI-DI
B-10705032015004
FDA product code
OEZ
EMDN code
C0104010101 Cardiac angiography diagnostic catheters
GMDN term
Angiographic catheter, single-use
Device class
Class III EUDAMED
Class II GUDID
Regulation number
870.1200
EU registration type
Legacy device (under a directive)
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
538-494P
GUDID
538494P
Device classEUDAMED
Class III
GUDID
Class II

Device class is stated on each registry's own scale: Class III 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: Angiographic catheter, single-use

Similar devices in this category

Other devices filed under CARDIAC ANGIOGRAPHY DIAGNOSTIC DEVICES,.

Other devices from Cordis US Corp.

See all devices from Cordis US Corp. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)