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hyflex-11-925_hyflex®-11-925_eu_20230807_declaration of conformity

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3. 3111 EU DECLARATION OF CONFORMITY declares under his sole responsibility, that the PPE described hereafter: HyFlex 11-925 Products manufactured till: [2019/10/27] PPE to be used against category II 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 388:2003, EN 420:2003 + A1:2009 and is identical to the PPE which is subject to the EC Type examination; under certificate number 032/2015/0640 issued by the Notified Body: CENTEXBEL (0493) TECHNOLOGIEPARK 70 B-9052 ZWIJNAARDE BELGIUM and is subject to the procedure set out in Annex VI (Module C) of the Regulation. Guido Van Duren Director - Regulatory affairs Ansell Place: Brussels Date: 2015/06/02

1. 4111A X1XXXX EU DECLARATION OF CONFORMITY declares under his sole responsibility, that the PPE described hereafter: HyFlex 11-925 Products manufactured as of: [2021/12/14] 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, EN407:2020 , EN ISO 21420:2020, ISO 18889:2019 and is identical to the PPE which is subject to the EU-Type examination (Module B, Annex V of the Regulation), under certificate number 032/2021/1386, 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: 2021/12/14

2. 4111A EU DECLARATION OF CONFORMITY declares under his sole responsibility, that the PPE described hereafter: HyFlex 11-925 Products manufactured as of: [2019/10/28] and till: [2021/12/13] 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, EN 420:2003 + A1:2009, ISO 18889:2019 and is identical to the PPE which is subject to the EU-Type examination (Module B, Annex V of the Regulation), under certificate number 032/2019/1589, 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: 2019/10/28

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