alphatec-58-128_alphatec®-58-128_eu_20231116_declaration of conformity

1. 2121A JKLOPT EU DECLARATION OF CONFORMITY declares under his sole responsibility, that the PPE described hereafter: AlphaTec 58-128 Products manufactured as of: [2021/08/19] PPE to be used against category III risks The Manufacturer ANSELL HEALTHCARE EUROPE N.V. RIVERSIDE BUSINESS PARK, BLOCK J BOULEVARD INTERNATIONAL 55 B-1070 BRUSSELS BELGIUM ® is in conformity with the provisions of Regulation (EU) 2016/425 and with the standards EN 388:2016 +A1:2018, EN ISO 21420:2020, EN ISO 374-1:2016, EN ISO 374-5:2016 and is identical to the PPE which is subject to the EU-Type examination (Module B, Annex V of the Regulation), under certificate number 032/2021/0793, issued by the Notified Body: CENTEXBEL (0493) TECHNOLOGIEPARK 70 B-9052 ZWIJNAARDE BELGIUM and is subject to the procedure set out in Annex VIII (Module D) of the Regulation under the supervision of the Notified Body: CENTEXBEL (0493) TECHNOLOGIEPARK 70 B-9052 ZWIJNAARDE BELGIUM Guido Van Duren Director - Regulatory affairs Ansell Place: Brussels Date: 2021/08/19

3. X121 EU DECLARATION OF CONFORMITY declares under his sole responsibility, that the PPE described hereafter: AlphaTec 58-128 Products manufactured till: [2018/05/01] PPE to be used against category III risks The Manufacturer ANSELL HEALTHCARE EUROPE N.V. RIVERSIDE BUSINESS PARK, BLOCK J BOULEVARD INTERNATIONAL 55 B-1070 BRUSSELS BELGIUM ® is in conformity with the provisions of Regulation (EU) 2016/425 and with the standards EN 374:2003, EN 388:2003, EN 420:2003 + A1:2009, and is identical to the PPE which is subject to the EC Type examination; under certificate number 032/2015/0115 issued by the Notified Body: CENTEXBEL (0493) TECHNOLOGIEPARK 70 B-9052 ZWIJNAARDE BELGIUM and is subject to the procedure set out in Annex VII (Module C2) of the Regulation under the supervision of the Notified Body: CENTEXBEL (0493) TECHNOLOGIEPARK 70 B-9052 ZWIJNAARDE BELGIUM Guido Van Duren Director - Regulatory affairs Ansell Place: Brussels Date: 2015/01/28

2. JKLOPT 2121A EU DECLARATION OF CONFORMITY declares under his sole responsibility, that the PPE described hereafter: AlphaTec 58-128 Products manufactured as of: [2018/05/02] and till: [2021/08/18] PPE to be used against category III risks The Manufacturer ANSELL HEALTHCARE EUROPE N.V. RIVERSIDE BUSINESS PARK, BLOCK J BOULEVARD INTERNATIONAL 55 B-1070 BRUSSELS BELGIUM ® is in conformity with the provisions of Regulation (EU) 2016/425 and with the standards EN ISO 374-1:2016, EN 388:2016, EN 420:2003 + A1:2009, EN ISO 374-5:2016 and is identical to the PPE which is subject to the EU-Type examination (Module B, Annex V of the Regulation), under certificate number 032/2018/0801.02, issued by the Notified Body: CENTEXBEL (0493) TECHNOLOGIEPARK 70 B-9052 ZWIJNAARDE BELGIUM and is subject to the procedure set out in Annex VII (Module C2) of the Regulation under the supervision of the Notified Body: CENTEXBEL (0493) TECHNOLOGIEPARK 70 B-9052 ZWIJNAARDE BELGIUM Guido Van Duren Director - Regulatory affairs Ansell Place: Brussels Date: 2018/05/02