Certificates

Quality & Compliance

Certificates

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

ISO 9001 ISO 13485 TUV CPAKB CDAKB Kemenkes BPAFK Sucofindo
ISO 9001 2015 Certificate
01 — QUALITY MANAGEMENT

ISO 9001:2015

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

Certified
ISO 13485 2016 Certificate
02 — MEDICAL DEVICES

ISO 13485:2016

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

Certified
CDAKB Certificate
03 — DISTRIBUTION PRACTICE

CDAKB Certification

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

Approved
IDAK Medical Device Distribution Permit
04 — DISTRIBUTION PERMIT

IDAK Permit

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

Authorized
CPAKB Certificate
05 — MANUFACTURING PRACTICE

CPAKB Certification

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

Approved
AKD Certification 1
06 — PRODUCT REGISTRATION

AKD BLOOD BANK REFRIGERATION PRODUCT MODEL LBB-101 GR

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

Registered
AKD Certification 2
07 — PRODUCT REGISTRATION

AKD BLOOD BANK REFRIGERATION PRODUCT MODEL LBB-102 GR

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

Registered
AKD Certification 2
08 — PRODUCT REGISTRATION

AKD BLOOD BANK REFRIGERATION PRODUCT MODEL LBB-103 GR

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

Registered
AKD Certification 4
09 — PRODUCT REGISTRATION

AKD BLOOD BANK REFRIGERATION PRODUCT MODEL LBB-104 GR

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

Registered
AKD Certification 5
10 — PRODUCT REGISTRATION

AKD BLOOD PLASMA FREEZER / BLASS FREEZER PRODUCT MODEL LBB-3010U

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

Registered
AKD Certification 6
11 — PRODUCT REGISTRATION

AKD BIO MEDICAL FREEZER PRODUCT MODEL LBF-4015U

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

Registered
AKD Certification 7
12 — PRODUCT REGISTRATION

AKD ULTRA LOW TEMP FREEZER - CASCADE REF SYSTEM PRODUCT MODEL LDF-9010U

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

Registered
AKD Certification 8
13 — PRODUCT REGISTRATION

AKD ULTRA LOW TEMP FREEZER - CASCADE REF SYSTEM PRODUCT MODEL LDF-9015U

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

Registered
AKL Certification 1
14 — PRODUCT REGISTRATION

AKL LARGE STEAM STERILIZER PRODUCT MODEL LAC-6205SP

Official imported medical device registration issued by the Indonesian Ministry of Health ensuring safety, quality, and efficacy.

Authorized
AKL Certification 2
15 — PRODUCT REGISTRATION

AKL LOW TEMPERATURE PLASMA STERILIZER PRODUCT MODEL LPS-1060T

Official imported medical device registration issued by the Indonesian Ministry of Health ensuring safety, quality, and efficacy.

Authorized
AKL Certification 3
16 — PRODUCT REGISTRATION

AKL LOW TEMPERATURE PLASMA STERILIZER PRODUCT MODEL LPS-1130F

Official imported medical device registration issued by the Indonesian Ministry of Health ensuring safety, quality, and efficacy.

Authorized
EMC BPAFK Certification 1
17 — TESTING & COMPLIANCE

EMC BPAFK Certification PRODUCT MODEL LAC-1031SV

Electromagnetic Compatibility (EMC) testing certification verified by BPAFK for equipment safety.

Approved
EMC BPAFK Certification 2
18 — TESTING & COMPLIANCE

EMC BPAFK Certification PRODUCT MODEL LBB-101 GR

Electromagnetic Compatibility (EMC) testing certification verified by BPAFK for equipment safety.

Approved
EMC BPAFK Certification 3
19 — TESTING & COMPLIANCE

EMC BPAFK Certification PRODUCT MODEL LBB-102 GR

Electromagnetic Compatibility (EMC) testing certification verified by BPAFK for equipment safety.

Approved
EMC BPAFK Certification 4
20 — TESTING & COMPLIANCE

EMC BPAFK Certification Product Model LBB-103GR

Electromagnetic Compatibility (EMC) testing certification verified by BPAFK for equipment safety.

Approved
EMC BPAFK Certification 5
21 — TESTING & COMPLIANCE

EMC BPAFK Certification Product Model LBB-104GR

Electromagnetic Compatibility (EMC) testing certification verified by BPAFK for equipment safety.

Approved
EMC BPAFK Certification 6
22 — TESTING & COMPLIANCE

EMC BPAFK Certification Product Model LBF-4015U

Electromagnetic Compatibility (EMC) testing certification verified by BPAFK for equipment safety.

Approved
EMC BPAFK Certification 7
23 — TESTING & COMPLIANCE

EMC BPAFK Certification Product Model LDF-9010U

Electromagnetic Compatibility (EMC) testing certification verified by BPAFK for equipment safety.

Approved
EMC BPAFK Certification 8
24 — TESTING & COMPLIANCE

EMC BPAFK Certification Product Model- LDF-9015U

Electromagnetic Compatibility (EMC) testing certification verified by BPAFK for equipment safety.

Approved
IEC 61010 Certification 1
25 — SAFETY STANDARDS

IEC 61010 Certification Product Model LBB-101 GR

Official test report of compliance with SNI IEC 61010-1:2016 safety standards issued by SUCOFINDO.

Approved
IEC 61010 Certification 2
26 — SAFETY STANDARDS

IEC 61010 Certification Product Model LBB-102 GR

Official test report of compliance with SNI IEC 61010-1:2016 safety standards issued by SUCOFINDO.

Approved
IEC 61010 Certification 3
27 — SAFETY STANDARDS

IEC 61010 Certification Product Model LBB-103 GR

Official test report of compliance with SNI IEC 61010-1:2016 safety standards issued by SUCOFINDO.

Approved
IEC 61010 Certification 4
28 — SAFETY STANDARDS

IEC 61010 Certification Product Model LBB-104 GR

Official test report of compliance with SNI IEC 61010-1:2016 safety standards issued by SUCOFINDO.

Approved
IEC 61010 Certification 5
29 — SAFETY STANDARDS

IEC 61010 Certification Product Model LBF-4015U

Official test report of compliance with SNI IEC 61010-1:2016 safety standards issued by SUCOFINDO.

Approved
IEC 61010 Certification 6
30 — SAFETY STANDARDS

IEC 61010 Certification Product Model LDF-9010U

Official test report of compliance with SNI IEC 61010-1:2016 safety standards issued by SUCOFINDO.

Approved
IEC 61010 Certification 7
31 — SAFETY STANDARDS

IEC 61010 Certification Product Model LDF-9015U

Official test report of compliance with SNI IEC 61010-1:2016 safety standards issued by SUCOFINDO.

Approved
IEC 61010 Certification 8
32 — SAFETY STANDARDS

IEC 61010 Certification Product Model LAC-1031SV

Official test report of compliance with SNI IEC 61010-1:2016 safety standards issued by SUCOFINDO.

Approved
Quality Assurance

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

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