EU Declaration of Conformity
In accordance with Art. 52 No. 7 of the EU Regulation EU 2017/745 of the Council on Medical Devices (of 05.04.2017) declares
SEGUFIX®-Bandagen, Das Humane System GmbH & Co. KG (SRN: DE-MF-000027702), hereby declares under sole responsibility that the basic safety and performance requirements according to Annex I of this regulation are met for the following medical device:
| Item 1206, Item 1204, Item 1205, Item 1216, Item 1214, Item 1215 | SEGUFIX®-Magnetic Lock black / segufix.com |
| Item 1208, Item 1218 | SEGUFIX®-Magnetic Key red |
Intended use:
- - Item 1206: closing of SEGUFIX® systems
- - Item 1208: quick release of the SEGUFIX®-Magnetic Lock black / segufix.com
The conformity assessment procedure according to Annexes II and III of the EU Regulation EU 2017/745 has been applied. This declaration is valid from the date of issue until May 24th, 2028.
EU Declaration of Conformity
In accordance with Art. 52 No. 7 of the EU Regulation EU 2017/745 of the Council on Medical Devices (of 05.04.2017) declares
SEGUFIX®-Bandagen, Das Humane System GmbH & Co. KG (SRN: DE-MF-000027702), hereby declares under sole responsibility that the basic safety and performance requirements according to Annex I of this regulation are met for the following medical device:
| Item 1306, Item 1304, Item 1305, Item 1316, Item 1314, Item 1315 | SEGUFIX®-Patent Twist Lock green |
| Item 1307, Item 1317 | SEGUFIX®-Patent Twist Key yellow |
Intended use:
- - Item 1306: closing of SEGUFIX® systems (for products manufactured after April 2003)
- - Item 1307: quick release of the SEGUFIX®-Twist Lock green
The conformity assessment procedure according to Annexes II and III of the EU Regulation EU 2017/745 has been applied. This declaration is valid from the date of issue until May 24th, 2028.
EU Declaration of Conformity
In accordance with Art. 52 No. 7 of the EU Regulation EU 2017/745 of the Council on Medical Devices (of 05.04.2017) declares
SEGUFIX®-Bandagen, Das Humane System GmbH & Co. KG (SRN: DE-MF-000027702), hereby declares under sole responsibility that the basic safety and performance requirements according to Annex I of this regulation are met for the following medical device:
| Item 1406, Item 1404, Item 1405 | SEGUFIX®-Push Lock / Push Button / Push Socket |
| Item 1408, Item 1417, Item 1418 | SEGUFIX®-Push Key |
Intended use:
- Art. 1406: For locking of SEGUFIX®-Systems (without magnetic mechanism, can be used in close proximity to pacemakers)
- Art. 1408: For opening of the push lock
The conformity assessment procedure according to Annexes II and III of the EU Regulation EU 2017/745 has been applied. This declaration is valid from the date of issue until May 24th, 2028.