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Esaote MyLabX1 Ultrasound Transducer_Convex Linear Array C62B_T3300

by Qisda Corporation

Ref 9J.2SG21.934Model InnoSight/T3300/H1300

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04719873009480 UDI-DI Date1 Oct 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number471987300VIVAPRO5J Basic UDI-DI 04719873009480UDI-DIDate10 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  • Withdrawn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
Esaote EUDAMED
"Esaote MyLabX1" Ultrasound Transducer_Convex Linear Array GUDID
Generic Name
Extracorporeal ultrasound imaging transducer, hand-held
Device Name
Diagnostic Ultrasound System
Model / Reference
InnoSight/T3300/H1300 EUDAMED
9J.2SG21.934 EUDAMED
C62B_T3300 GUDID
Primary DI / UDI-DI
04719873009480
Basic UDI-DI
471987300VIVAPRO5J
Direct Marketing DI
04719873009480
FDA Product Code
ITW
EMDN Code
Z11040103 Portable ultrasound scanners
GMDN Term
Extracorporeal ultrasound imaging transducer, hand-held
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
890.3475
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
InnoSight/T3300/H1300
9J.2SG21.934
GUDID
C62B_T3300
Device ClassEUDAMED
Class IIa
GUDID
Class I

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Properties

Other properties (24)

  • 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
  • Prescription Use: 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