Certificates

Quality & Compliance

Certificates

Our certifications and regulatory approvals demonstrate our commitment to quality, safety, and compliance in laboratory, medical, and industrial equipment manufacturing.

01 — QUALITY MANAGEMENT

ISO 9001:2015

Quality Management System certification supporting consistent manufacturing processes, product quality, and continuous improvement.

Certified

02 — MEDICAL DEVICES

ISO 13485:2016

Quality Management System certification specifically established for medical device design, manufacturing, and regulatory compliance.

Certified

03 — DISTRIBUTION PRACTICE

CDAKB Certification

Good Distribution Practice certification for medical devices issued in accordance with Indonesian regulatory requirements.

Approved

04 — DISTRIBUTION PERMIT

IDAK Permit

Official medical device distribution permit supporting authorized distribution activities within Indonesia.

Authorized

05 — MANUFACTURING PRACTICE

CPAKB Certification

Good Manufacturing Practice certification supporting controlled and compliant medical device production processes.

Approved

AKD and AKL Medical Device Certification

06 — PRODUCT REGISTRATION

AKD Certifications

Product certifications and registration approvals issued by the Indonesian Ministry of Health for domestic and imported medical devices.

Registered

07 — PRODUCT REGISTRATION

AKL Certifications

Official product registration issued by the Indonesian Ministry of Health, ensuring the medical device complies with national safety, quality, and efficacy standards for commercial distribution.

Authorized

08 — MANUFACTURING PRACTICE

EMC BPAFK Certification

Electromagnetic Compatibility (EMC) testing certification verified by BPAFK, guaranteeing the equipment operates safely without causing or being affected by electromagnetic interference.

Approved

09 — MANUFACTURING PRACTICE

IEC 61010 Certification

Official test report of compliance with SNI IEC 61010-1:2016 safety standards issued by SUCOFINDO, ensuring maximum electrical safety for laboratory, control, and measurement equipment.

Approved

Quality Assurance

These certifications support our commitment to responsible manufacturing, regulatory compliance, product safety, and dependable customer service.

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