Regulatory Requirement of ESU-Pencil

Sep 02, 2021 Leave a message

The product ESU-Pencil complies with regulatory requirements of the European Directive 93/42/EEC concerning medical devices.

Classification:

MDD 93/42/EEC classification: 

Class IIb according to Rule 9 

Model of operation: 

Continuous Operation

Degree of protection against electric shock: 

Type BF Applied part 

Electric shock protection grade: 

The electric shock protection grade of the product depends on the connected high frequency electrosurgery (generator) apparatus. Please refer to the user manual of the designated high frequency apparatus.


Jinhua Huacheng Medical Appliance Co.,Ltd.

Manufactuer of disposable medical products: Electrosurgical pencil,grounding plate,skin stapler and ECG electrode

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