Documents

Products

DECLARATIONS OF CONFORMITY

Medical masks

• SANI DM 01
• SANI DM 02
• SANI DM 03
• SANI DM 04
• SANI DM 05
• SANI DM 06
• SANI DM 07
• SANI DM 08
• SANI DM 09
• SANI DM 10
• SANI DM 11
• SANI DM 12

Protective masks

• OPP2
• OPP2 EN
• OPP2L
• OPP2L EN
• OPP3LZ
• OPP3LZ EN
• FOPP2
• FOPP2 EN

• Instructions for the use of Opharm medical masks
• Instructions for fitting the Opharm protective mask
• GLOSSARY OF SYMBOLS
• INCIDENT NOTIFICATION FORM

CERTIFICATES

Protective masks

• CW-PPER-3-06-2023 (module B) rev.2
• CW-PPER-32-10-2021 REV 2
• CW-PPER-31-10-2021 REV 2
• CW-PPER-13-05-2026
• CW-PPER-1-02-2022 REV1
• CW-PPER-1-02-2022 REV 1 Annex 2026-06-23

Management systems

• 9001 PL
• 9001 EN
• 13485 PL
• 13485 EN
• ISO 22716 PL

• QUALITY POLICY OF IMS