alphatec-87-104_alphatec®-87-104_eu_20231120_declaration of conformity

6. A B C K L 4121 EU DECLARATION OF CONFORMITY declares under his sole responsibility, that the PPE described hereafter: Emperor™ ME104 Products manufactured till: [2019/02/28] 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 CE 619846 issued by the Notified Body: BSI (0086) KITEMARK COURT DAVY AVENUE KNOWLHILL MILTON KEYNES MK5 8PP UNITED KINGDOM and is subject to the procedure set out in Annex VIII (Module D) of the Regulation under the supervision of the Notified Body: BSI (0086) KITEMARK COURT DAVY AVENUE KNOWLHILL MILTON KEYNES MK5 8PP UNITED KINGDOM Guido Van Duren Director - Regulatory affairs Ansell Place: Brussels Date: 2015/07/16

1. 3121B AKLMPT EU DECLARATION OF CONFORMITY declares under his sole responsibility, that the PPE described hereafter: AlphaTec 87-104 Products manufactured as of: [2022/03/11] 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 032/2022/0379, 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: 2022/03/11

3. AKLMPT 3121B EU DECLARATION OF CONFORMITY declares under his sole responsibility, that the PPE described hereafter: AlphaTec 87-104 Products manufactured as of: [2019/07/31] and till: [2021/01/11] PPE to be used against category III risks The Manufacturer COMASEC S.A.S 5 ALLÉE DES BAS TILLIERS 92238 GENNEVILLIERS CEDEX FRANCE ® 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 032/2019/0358, 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: 2019/07/31

5. AKLMPT 3121B EU DECLARATION OF CONFORMITY declares under his sole responsibility, that the PPE described hereafter: AlphaTec 87-104 Products manufactured as of: [2019/03/01] and till: [2019/07/24] 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 032/2019/0358, 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: BSI (0086) KITEMARK COURT DAVY AVENUE KNOWLHILL MILTON KEYNES MK5 8PP UNITED KINGDOM Guido Van Duren Director - Regulatory affairs Ansell Place: Brussels Date: 2019/03/01

2. AKLMPT 3121B EU DECLARATION OF CONFORMITY declares under his sole responsibility, that the PPE described hereafter: AlphaTec 87-104 Products manufactured as of: [2021/01/12] and till: [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 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 032/2019/0358.02, 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: 2021/01/12

4. AKLMPT 3121B EU DECLARATION OF CONFORMITY declares under his sole responsibility, that the PPE described hereafter: AlphaTec 87-104 Products manufactured as of: [2019/07/25] and till: [2019/07/30] 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 032/2019/0358, 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: BSI GROUP THE NETHERLANDS B.V. (2797) SAY BUILDING, JOHN M. KEYNESPLEIN 9, 1066 EP AMSTERDAM NETHERLANDS Guido Van Duren Director - Regulatory affairs Ansell Place: Brussels Date: 2019/07/25