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Affiniti CVx Diagnostic Ultrasound System Circular Edition 795407

by Philips Ultrasound LLC

Ref 795407

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
United StatesGUDID listing GUDID Number00884838126947 UDI-DI Date23 Jun 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0884838BM432ST Basic UDI-DI 00884838126947UDI-DIDate22 May 2023RegisteredStatusActive

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  • Withdrawn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
Affiniti Diagnostic Ultrasound System EUDAMED
Affiniti CVx Diagnostic Ultrasound System Circular Edition GUDID
Generic Name
General-purpose ultrasound imaging system
Device Name
Affiniti Series Diagnostic Ultrasound System
Model / Reference
795407
Primary DI / UDI-DI
00884838126947
Basic UDI-DI
0884838BM432ST
FDA Product Code
IYN, IYO, ITX, OBJ, QIH
EMDN Code
Z11040104 Multidisciplinary ultrasound scanners (internal and cardiology, etc.)
GMDN Term
General-purpose ultrasound imaging system
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.1550, 892.1560, 892.1570, 870.1200, 892.2050
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

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Properties

  • Measuring Function
  • Prescription Use
  • Serial Number

Other properties (21)

  • 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
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No