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Blood bags stored on stainless steel shelves inside a blood bank refrigerator

QUALITY & COMPLIANCE

Certified quality for critical blood processes

Presvac designs, manufactures and services its equipment under ISO 13485 and ISO 9001 quality management systems, certified by RINA (Italy). Its products are registered with ANMAT, the Argentine health authority.

CERTIFICATES

Download our certificates

Use these documents for tenders, supplier qualification and approval processes. If you need a certificate in another format, write to us and we will send it.

MEDICAL DEVICES

ISO 13485

Quality management system for medical devices: design, development, production and technical service of Presvac equipment. First certified in 2006. Issued by RINA (Italy).

Download ISO 13485 certificate (PDF)
QUALITY MANAGEMENT

ISO 9001

Quality management system certified for Presvac. Issued by RINA (Italy).

Download ISO 9001 certificate (PDF)
HEALTH AUTHORITY · ARGENTINA

ANMAT

Presvac is registered with ANMAT as a medical device manufacturer under PM 1532. Each product line has its own registration number.

View registrations

ANMAT REGISTRATIONS

Registered with the Argentine health authority

Presvac equipment is registered with ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) under the manufacturer registration PM 1532.

PM 1532-1

Centrifuges

Refrigerated blood bag centrifuges and laboratory centrifuges.

PM 1532-2

Platelet storage

Platelet agitators and incubators: AP-48 L, AP-96 L, AP-48 LT and AP-96 LT.

PM 1532-3

Collection and processing

AE-500A blood collection mixer and Plasma Soft plasma thawer.

PM 1532-4

Blood bank refrigerators

FEDE-4 and FEDE-4-2 blood bank refrigerators.

PM 1532-5

Freezers

FEDE-35 biomedical freezer and FH-80 vertical −80 °C ultra-low freezer.

Need help choosing the right equipment?

Tell us about your application and technical requirements. Our team will help you define the right configuration.