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Direct AO cable Utah transducer

by Opsens Inc.

Ref F201322Model AO Cable

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number07540184F201323 Basic UDI-DI 07540184013227UDI-DIDate15 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07540184013227 UDI-DI Date4 May 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
Direct AO cable Utah transducer EUDAMED
OptoMonitor 3 GUDID
Generic Name
Cardiac catheterization laboratory computer
Device Name
AO cable Philips/WITT
Model / Ref / Catalog
AO Cable, F201322, Direct AO cable - Utah transducer
Primary DI / UDI-DI
07540184013227
Basic UDI-DI
07540184F201323
510(k) Number
FDA Product Code
DXO
EMDN Code
Z12050580 Cardiac output measurement instruments - hardware accessories
GMDN Term
Cardiac catheterization laboratory computer
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
870.2870
EU market of registration
Hungary
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
AO Cable
F201322
GUDID
Direct AO cable - Utah transducer
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
CA-MF-000018361
Authorised representative
Haemonetics Italia s.r.l IT-AR-000021067

Other devices from Opsens Inc.

Properties

  • Prescription Use

Other properties (23)

  • Sterile: No
  • Single Use: No
  • 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
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No