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Inquiry™ IBI-81223

by Irvine Biomedical, Inc.

Part of a family of 46 devices: see the family page

Ref IBI-81223

Inquiry™ IBI-81223 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 5414734DMS0011HQ) and listed in FDA GUDID since 10 Feb 2015 (UDI-DI 05414734303637), active as of 7 Nov 2026.

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

CE MDR

Valid until

7 Jul 2027

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5414734DMS0011HQ Basic UDI-DI 05414734303637UDI-DIDate28 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05414734303637 UDI-DI Date10 Feb 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 5414734DMS0011HQ registered 28 Aug 2026 Active
  • FDA GUDID UDI-DI 05414734303637 listed 10 Feb 2015 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 751167 Expiring Amended Expires in 237 days

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    6 Feb 2026
    Expires
    7 Jul 2027
    Reason
    Other

Timeline

2 dated events

  1. Listed FDA GUDID 05414734303637
  2. Registered EUDAMED 5414734DMS0011HQ

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  • Withdrawn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™
Generic name
Cardiac mapping catheter, percutaneous, single-use
Device name
Inquiry Diagnostic Catheter
Model / Ref / Catalog
IBI-81223
Primary DI / UDI-DI
05414734303637
Basic UDI-DI
5414734DMS0011HQ
FDA product code
DRF
EMDN code
C02010401 Arrhythmology multipolar diagnostic catheters, conventional
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 — 5 French

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 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
  • Manufacturing date
Other properties (19, all answered No)