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Esaote MyLabX1 Ultrasound Transducer_Phased Array P42B6_T3300

by Qisda Corporation

Ref 9J.2SG11.935Model 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 Number04719873009534 UDI-DI Date1 Oct 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number471987300VIVAPRO5J Basic UDI-DI 04719873009534UDI-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 AmericaIrelandMalta
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

EU market availability

Made available in 2 countries, as listed in EUDAMED:

Declared by the manufacturer in EUDAMED for this device version; may not cover every market.

  • Ireland since 1 Dec 2024
  • Malta since 1 Dec 2024

Last checked 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Esaote EUDAMED
"Esaote MyLabX1" Ultrasound Transducer_Phased Array GUDID
Generic Name
Extracorporeal ultrasound imaging transducer, hand-held
Device Name
Diagnostic Ultrasound System
Model / Reference
InnoSight/T3300/H1300 EUDAMED
9J.2SG11.935 EUDAMED
P42B6_T3300 GUDID
Primary DI / UDI-DI
04719873009534
Basic UDI-DI
471987300VIVAPRO5J
Direct Marketing DI
04719873009534
FDA Product Code
ITX
EMDN Code
Z11040103 Portable ultrasound scanners
GMDN Term
Extracorporeal ultrasound imaging transducer, hand-held
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.1570
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.2SG11.935
GUDID
P42B6_T3300
Device ClassEUDAMED
Class IIa
GUDID
Class II

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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