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Ultrasonic Surgical Handpiece

EUDAMED

Class IIb (EU MDR)

Ref HP401Model HP401，HP501

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

Identity

Device Name
Ultrasonic Surgical Handpiece EUDAMED
Model / Reference
HP401，HP501 EUDAMED
HP401 EUDAMED

Identifiers

Primary DI / UDI-DI
06972464940113 EUDAMED
Basic UDI-DI
697246494MD03002USHP0012P EUDAMED
EMDN Code
Z12010880 INSTRUMENTS FOR ULTRASONIC SURGERY - HARDWARE ACCESSORIES EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
Greece 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

Category: Ultrasonic surgical system generator

Ultrasonic Surgical Handpiece by Innolcon Medical Technology (Suzhou) 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
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 01a0bf3f-4cb5-4af0-bf2a-48b5114bacd8 61 fields · synced Jul 14, 2026