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Ultrasonic Surgical and Electrosurgical Generator

EUDAMED

Class IIb (EU MDR)

Ref Solar

by Wuxi Beien Surgery Device Co., Ltd.

Identity

Trade Name
Ultrasonic Surgical and Electrosurgical Generator EUDAMED
Device Name
Ultrasonic Surgical and Electrosurgical Generator EUDAMED
Model / Reference
Solar EUDAMED

Identifiers

Primary DI / UDI-DI
06971767873104 EUDAMED
Basic UDI-DI
697176787SolarFP EUDAMED
EMDN Code
Z12010880 INSTRUMENTS FOR ULTRASONIC SURGERY - HARDWARE ACCESSORIES EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
Ireland 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

Ultrasonic Surgical and Electrosurgical Generator by Wuxi Beien Surgery Device Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS

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
Wuxi Beien Surgery Device Co., Ltd.
EUDAMED SRN
CN-MF-000017684
Authorised Representative
Prolinx GmbH DE-AR-000005129

Sources (1)

  • EUDAMED 49a8e181-37a3-4ef5-b84e-51174294387b 61 fields · synced Jul 10, 2026