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Risk class:

Class IIb

Classification rule:

Rule 16

Classification:

The 

Page lookup error: page "Device and Trade Name (OPT-PER)" not found.

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is a Class IIb medical device.

Page lookup error: page "Justification (OPT-PER)" not found.

If you're experiencing issues please see our Troubleshooting Guide.

Risk class_DE:

There were errors rendering macro:

  • An unknown error occurred.

Classification rule_DE:

Regel 16

Classification_DE:

Das 

Page lookup error: page "Device and Trade Name (OPT-PER)" not found.

If you're experiencing issues please see our Troubleshooting Guide.

ist ein Klasse IIb Medizinprodukt.

Page lookup error: page "Justification (OPT-PER)" not found.

If you're experiencing issues please see our Troubleshooting Guide.