Acme Filter Mask, Inc.
Quality Excellence Since 1986

Quality Certifications

Since 1986, Acme Filter Mask has earned multiple certifications from Taiwan FDA, ISO, and CNS — each certificate represents our commitment to medical mask and meltblown nonwoven quality.

Domestic & International Certifications

Acme Filter Mask Inc. holds multiple international quality standards and product certifications, ensuring our medical masks, industrial protective masks, and meltblown nonwoven filter media meet global market requirements — including ISO 9001, ISO 13485, GMP for Medical Devices, and various Taiwan FDA medical device licenses, CNS ink and fluorescent test reports.

International Standards

ISO 9001:2016 Quality Management
ISO 9001:2015 (CNS 12681:2016) Quality Management
ISO 13485:2016 Medical Devices Quality Management
ISO 13485:2016 Medical Devices Quality Management

Taiwan FDA Medical Device Licenses

Taiwan FDA Medical Device Manufacturing License
Taiwan FDA Medical Device Manufacturing License (QMS5208)
Taiwan FDA Class I Medical Device License No. 007080
Taiwan FDA Class I Medical Device License No. 007080
Taiwan FDA Class I Medical Device License No. 005419
Taiwan FDA Class I Medical Device License No. 005419
Taiwan FDA Surgical Grade License No. 003961
Taiwan DOH Medical Device License No. 003961
Taiwan FDA Class I Medical Device License
Taiwan DOH Class I Medical Device License No. 003493 (Activated Carbon)

GMP Medical Device Manufacturing

GMP - Good Manufacturing Practice Certification
Taiwan FDA Medical Device GMP Certificate (GMP0920)

Business Licenses

Pharmaceutical Manufacturer License
Medical Device Manufacturer License (MD6131000763)
Pharmaceutical Distributor License
Pharmaceutical Distributor License (6231081508)

CNS Test Reports

Printing Ink Safety Test Report
Printing Ink Safety Test Report
CNS15290 Azo & Formaldehyde / CNS11820 Fluorescent Test Report (Black, Purple)
CNS15290 Azo & Formaldehyde / CNS11820 Fluorescent Test Report (Black, Purple)
CNS15290 Azo & Formaldehyde / CNS11820 Fluorescent Test Report (Neon Green, Bright Orange)
CNS15290 Azo & Formaldehyde / CNS11820 Fluorescent Test Report (Neon Green, Bright Orange)
CNS15290 Azo & Formaldehyde / CNS11820 Fluorescent Test Report (Camo Black, Camo Blue, Camo Green)
CNS15290 Azo & Formaldehyde / CNS11820 Fluorescent Test Report (Camo Black, Camo Blue, Camo Green)
CNS15290 Azo & Formaldehyde / CNS11820 Fluorescent Test Report (Rabbit, Excavator)
CNS15290 Azo & Formaldehyde / CNS11820 Fluorescent Test Report (Rabbit, Excavator)

Awards & Recognitions

ROC 109 National Day Appreciation Letter
ROC 109 National Day Appreciation Letter

Need detailed certification data or custom certification support? Contact our sales team.

Contact Sales