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Integrated Ultrasonic & High Frequency Surgical Generator

EUDAMED

Class IIb (EU MDR)

Ref Y20GEN

by Innolcon Medical Technology (Suzhou) Co., Ltd.

Identity

Device Name
Integrated Ultrasonic & High Frequency Surgical Generator EUDAMED
Model / Reference
Y20GEN EUDAMED

Identifiers

Primary DI / UDI-DI
06972464940038 EUDAMED
Basic UDI-DI
697246494MD03010UHSE001X2 EUDAMED
EMDN Code
Z12010880 INSTRUMENTS FOR ULTRASONIC SURGERY - HARDWARE ACCESSORIES EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
France EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

Yes

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

Category: Ultrasonic surgical system generator

Integrated Ultrasonic & High Frequency Surgical Generator by Innolcon Medical Technology (Suzhou) Co., Ltd. — Class IIb — MDR — listed in EUDAMED

Similar devices

Also classified as Ultrasonic surgical system generator.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Innolcon Medical Technology (Suzhou) Co., Ltd.
EUDAMED SRN
CN-MF-000012689
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (1)

  • EUDAMED 7770b4c8-54ab-4e49-b757-5315bf635c05 61 fields · synced Jul 18, 2026