Thanks for submitting the form. You are about to download the Declaration of Conformity of the SAGA 32+ and SAGA 64+.

SAGA32/64+ is certified as Medical Device in the EU region. Outside the EU it is not certified or registered as Medical Device.

Please select the DoC that applies to your situation. If you are not certain about which version to download, follow the steps below.

EU REGION

English | 92-1000-0100-EN-4-0 EU Declaration of Conformity

Translations

POLISH | 92-1000-0100-PL-4-0

Download (PDF)

SPANNISH | 92-1000-0100-ES-4-0

Download (PDF)

SWEDISH | 92-1000-0100-SV-4-0

Download (PDF)

NON-EU REGION

English | 92-1000-0200-EN-3-0 EU Declaration of Conformity

HELP ME CHOOSE

1. Identify the REF code of your device. This number can be found on the back of the Data Recorder or Docking Station and on the packing list of your order.

2. The REF code has the following structure: 95-1000-AB00-0-1. A can be 2 or 4, identifying the 32 or 64 channel version.

3. B is the region code. If B = 1: Download the EU region version. If B = 2: Download the Non-EU version.

STILL NOT CLEAR?

Download both versions and consult support@tmsi.com for further information.

PRODUCT DOCUMENTATION

SAGA 32/64+

Declaration of Conformity