alphatec-79-700_alphatec®-79-700_eu_20231121_declaration of conformity (1)

3. 1001 EU DECLARATION OF CONFORMITY declares under his sole responsibility, that the PPE described hereafter: Virtex 79-700 Products manufactured till: [2018/08/05] 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 032/2015/0140 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: 2015/02/10

1. 1001A JKT EU DECLARATION OF CONFORMITY declares under his sole responsibility, that the PPE described hereafter: AlphaTec 79-700 Products manufactured as of: [2022/03/10] 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 421:2010, 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 032/2022/0363, 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: 2022/03/10

2. JKT 1001A EU DECLARATION OF CONFORMITY declares under his sole responsibility, that the PPE described hereafter: AlphaTec 79-700 Products manufactured as of: [2018/08/06] and till: [2022/03/09] 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 Type B, EN 388:2016, EN 420:2003 + A1:2009, EN ISO 374-5:2016, EN 421:2010 and is identical to the PPE which is subject to the EU-Type examination (Module B, Annex V of the Regulation), under certificate number 032/2018/0311.02, 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: 2018/08/06