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Esaote

EUDAMED

Class IIa (EU MDR)

Ref 9J.2SG31.139Model InnoSight/T3300/H1300Ref 9J.2SG01.035Ref 9J.2SG21.935Ref 9J.5KYBG.E21

by Qisda Corporation

Identity

Trade Name
Esaote EUDAMED
Device Name
Diagnostic Ultrasound System EUDAMED
Model / Reference
InnoSight/T3300/H1300 EUDAMED
9J.2SG31.139 EUDAMED
9J.2SG01.035 EUDAMED
9J.2SG21.935 EUDAMED
9J.5KYBG.E21 EUDAMED

Identifiers

Primary DI / UDI-DI
04719873009985 EUDAMED
04719873009930 EUDAMED
04719873009947 EUDAMED
04719873001132 EUDAMED
Basic UDI-DI
471987300VIVAPRO5J EUDAMED
Direct Marketing DI
04719873009985 EUDAMED
04719873009930 EUDAMED
04719873009947 EUDAMED
04719873001132 EUDAMED
EMDN Code
Z11040103 PORTABLE ULTRASOUND SCANNERS EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Ireland EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Esaote by Qisda Corporation — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Qisda Corporation
EUDAMED SRN
TW-MF-000010709
Authorised Representative
MedNet EC-REP GmbH DE-AR-000000002

Sources (4)

  • EUDAMED 873e8966-a93a-4001-8525-3c9f50c54ad5 61 fields · synced Jul 30, 2026
  • EUDAMED 5b34a6ac-0527-4b1d-9a63-bf6c7d354f9a 61 fields · synced May 18, 2026
  • EUDAMED 0c3f416b-f9e8-4517-8644-917ef2dafb06 61 fields · synced May 18, 2026
  • EUDAMED 8c3fb8cb-02dc-4202-a853-9eb6b4c11b36 61 fields · synced May 19, 2026