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Vivid Focus

by GE Vingmed Ultrasound A/S

Ref Vivid Focus/TC001013Model Vivid Explorer, Vivid Advanced, Vivid Focus

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 25 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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00198953126073 UDI-DI Date21 Sep 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number08406821BUG0061173 Basic UDI-DI 00198953126073UDI-DIDate11 Aug 2025RegisteredStatusActive

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 25 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  • Withdrawn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
Vivid Focus EUDAMED
Vivid GUDID
Generic Name
Cardiovascular ultrasound imaging system
Device Name
Vivid Explorer, Vivid Advanced, Vivid Focus
Model / Ref / Catalog
Vivid Explorer EUDAMED
Vivid Advanced EUDAMED
Vivid Focus EUDAMED
Vivid Focus/TC001013 EUDAMED
Focus GUDID
TC001011 GUDID
Primary DI / UDI-DI
00198953126073
Basic UDI-DI
08406821BUG0061173
Direct Marketing DI
00198953126073
510(k) Number
FDA Product Code
ITX, IYN, IYO, QIH
EMDN Code
Z11040102 Cardiology ultrasound scanners
GMDN Term
Cardiovascular ultrasound imaging system
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.1570, 892.1550, 892.1560, 892.2050
EU market of registration
Norway
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Vivid Explorer, Vivid Advanced, Vivid Focus
Vivid Focus/TC001013
GUDID
Focus
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K261313)

Other devices from GE Vingmed Ultrasound A/S

See all devices from GE Vingmed Ultrasound A/S →

Properties

  • Measuring Function
  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • 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