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Certificates

Empowering Excellence through Unmatched Quality

Alpha-Bio Tec.'s medical devices are compliant with international standards, laws, and regulatory requirements of the Medical Industry. At Alpha-Bio Tec. we view quality as a pivotal pillar of our mission & vision, to provide you & your patients with safe, reliable & efficient products.

View or download the certificates you need

MDR Certificate - Alpha Bio Tec

MDR EU
2017/745

Quality Management System
 

MDD Certificate - Alpha Bio Tec

MDD
93/42/EEC

Full Quality Assurance System

CERTIFICATE_ISO_Alpha_Bio_TEC

Quality System Certificate (ISO 13485)

Quality Management System

Certificate_Israel - Alpha Bio Tec

Israel

AMAR, Israeli Ministry of Health department

Alpha-Bio-Tec_certificate_Russia

Russia

RZN Ministry of Health

Certificate_Belarus - Alpha Bio Tec

Belarus

Ministry of Health of the republic of Belarus

Certificate_Kazakhstan - Alpha Bio Tec

Kazakhstan

Ministry of Healthcare of the Republic of Kazakhstan

Certificate_Moldova - Alpha Bio Tec

Moldova

Ministry of Health of the republic of Moldova

Certificate_Ukraine - Alpha Bio Tec

Ukraine

Ministry of Health of Ukraine

Certificate Serbia - Alpha Bio Tec

Serbia

Ministry of Health of the Republic of Serbia

Certificate_China - Alpha Bio Tec

China

Ministry of Health, State Food and Drug Administration

Certificate India - Alpha Bio Tec

India

CDSCO Central Drugs Standard Control Organization (Ministry of Health)

Certificate Taiwan - Alpha Bio Tec

Taiwan

TFDA Ministry of Health

Certificate Argentina - Alpha Bio Tec

Argentina

National Administration of Medicines, Food and Medical Technology (ANMAT)

Certificate Colombia - Alpha Bio Tec

Colombia

National Institute for Drug Surveillance and Food (INVIMA)

Certificate Ecuador - Alpha Bio Tec

Ecuador

Ecuador Ministry of Health (MSP)

Certificate Mexico - Alpha Bio Tec

Mexico

COFEPRIS - Mexico Ministry of Health

Certificate Uruguay - Alpha Bio Tec

Uruguay

Uruguay Ministry of Public Health - Department of Technology Assessment

MDR Certificate - Alpha Bio Tec

MDR EU
2017/745

Quality Management System
 

MDD Certificate - Alpha Bio Tec

MDD
93/42/EEC

Full Quality Assurance System

CERTIFICATE_ISO_Alpha_Bio_TEC

Quality System Certificate (ISO 13485)

Quality Management System

Certificate_Israel - Alpha Bio Tec

Israel

AMAR, Israeli Ministry of Health department

Alpha-Bio-Tec_certificate_Russia

Russia

RZN Ministry of Health

Certificate_Belarus - Alpha Bio Tec

Belarus

Ministry of Health of the republic of Belarus

Certificate_Kazakhstan - Alpha Bio Tec

Kazakhstan

Ministry of Healthcare of the Republic of Kazakhstan

Certificate_Moldova - Alpha Bio Tec

Moldova

Ministry of Health of the republic of Moldova

Certificate_Ukraine - Alpha Bio Tec

Ukraine

Ministry of Health of Ukraine

Certificate Serbia - Alpha Bio Tec

Serbia

Ministry of Health of the Republic of Serbia

Certificate_China - Alpha Bio Tec

China

Ministry of Health, State Food and Drug Administration

Certificate India - Alpha Bio Tec

India

CDSCO Central Drugs Standard Control Organization (Ministry of Health)

Certificate Taiwan - Alpha Bio Tec

Taiwan

TFDA Ministry of Health

Certificate Argentina - Alpha Bio Tec

Argentina

National Administration of Medicines, Food and Medical Technology (ANMAT)

Certificate Colombia - Alpha Bio Tec

Colombia

National Institute for Drug Surveillance and Food (INVIMA)

Certificate Ecuador - Alpha Bio Tec

Ecuador

Ecuador Ministry of Health (MSP)

Certificate Mexico - Alpha Bio Tec

Mexico

COFEPRIS - Mexico Ministry of Health

Certificate Uruguay - Alpha Bio Tec

Uruguay

Uruguay Ministry of Public Health - Department of Technology Assessment