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Inquiry™ AFocus II™ IBI-87008

by Irvine Biomedical, Inc.

Ref IBI-87008

Inquiry™ AFocus II™ IBI-87008 is a device classified as Class III in the EU and Class II in the US made by Irvine Biomedical, Inc., registered in EUDAMED on 28 Aug 2026 (Basic UDI-DI 5414734DMS0010HN) and listed in FDA GUDID since 22 May 2015 (UDI-DI 05414734309929), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5414734DMS0010HN Basic UDI-DI 05414734309929UDI-DIDate28 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05414734309929 UDI-DI Date22 May 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 5414734DMS0010HN registered 28 Aug 2026 Active
  • FDA GUDID UDI-DI 05414734309929 listed 22 May 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05414734309929
  2. Registered EUDAMED 5414734DMS0010HN

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  • Withdrawn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
Inquiry™ AFocus II™
Generic name
Cardiac mapping catheter, percutaneous, single-use
Device name
Inquiry AFocus Diagnostic Catheter
Model / Ref / Catalog
IBI-87008
Primary DI / UDI-DI
05414734309929
Basic UDI-DI
5414734DMS0010HN
FDA product code
DRF
EMDN code
C02010499 Arrhythmology multipolar diagnostic catheters – other
GMDN term
Cardiac mapping catheter, percutaneous, single-use
Device class
Class III EUDAMED
Class II GUDID
Regulation number
870.1220
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Size
Catheter Gauge — 7 French
Length — 110.0000 Centimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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: Cardiac mapping catheter, percutaneous, single-use

Similar devices in this category

Other devices filed under ARRHYTHMOLOGY MULTIPOLAR DIAGNOSTIC CATHETERS – OTHER.

Other devices from Irvine Biomedical, Inc.(Ibi)

See all devices from Irvine Biomedical, Inc.(Ibi) →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)