Medical Devices
At Galenica Health, we provide an extensive array of essential medical devices designed to address cost and safety concerns, especially in times of heightened global demand. Our range includes USFDA and EU-approved medical-grade Personal Protective Equipment (PPEs), crucial for frontline workers and government agencies across the region. Additionally, we offer our exclusive line of Ultra-Cold freezers and portable coolers, delivering reliable storage and distribution solutions for vaccines and biological materials.
In the United States, the FDA plays a crucial role in ensuring the safety and effectiveness of medical devices throughout their lifecycle. Collaborating closely with local and foreign manufacturers, the FDA facilitates regulatory compliance and takes enforcement actions as necessary to uphold safety and efficacy standards.
At Galenica, we exclusively procure medical devices that adhere to rigorous standards and specifications, including FDA, ISO 9001, ISO 14001, ISO 13485, OHSAS 18001, and the European Union (CE) mark. Our commitment to quality extends further with local presence in the country of origin, ensuring proper regulatory certifications and compliance with local laws and standards. Boots on the ground allow us to monitor product quality and packaging before shipment, ensuring compliance with current customs clearance SOPs at the port of origin and destination.
MEDICAL GRADE PPE
Personal protective equipment (PPE) has played a vital role in protecting the frontline workers during the pandemic. Inappropriate and poor-quality PPE kits can contribute to infection spread, particularly among frontline workers. Therefore, the healthcare systems must prioritize the procurement and distribution of good quality and certifiable PPE.
Galenica sources PPE products that comply with all set standards - ASTM and GB2626 Specifications, FDA, ISO 9001, ISO 14001, ISO 13485, OHSAS 18001 and European Union (EN) regulations. Our trained onsite staff checks and monitors all the manufacturing and packaging for these products, while also ensuring all certificates are genuine and legitimate.
With the strictest quality control checks in place, Galenica can provide all PPE products, including:
• Disposable 3-layer masks and KN95 masks.
• Tychem / Tyvek protective suits.
• Disposable isolation gowns.
• Surgical gowns.
ULTRA-COLD FREEZERS
Galenica offers storage and distribution solutions for different types of COVID-19 vaccines and biological samples. We guarantee compliance with the cold chain requirements during immunization programs across the region. All our PATAGONIA branded equipment are ISO 9001, ISO 13485, ISO 14001 certified and adaptable in environments with temperature ranges between 10°C and 32°C. Our solutions offer different temperature conditions, including:
Ultra-Cold Freezers
• -86°C Dual Cooling System comes with dual safety with two completely independent refrigeration systems. If one of these systems fail, the other can still maintain the interior temperature at -85°C.
• -86°C Cascade Cooling System comes with two separate refrigeration cycles. The design allows for maximum storage capacity and is ideal for the storage of vaccines or clinical samples.
• -86°C Self-Cascade System uses a single compressor. These freezers allow long-term storage of biological samples such as blood and plasma.
Ultra-Low Temperature Freezers
• -25°C to -30°C Mobile Cooler comes in a convenient, portable format and includes a constant alarm after shutdown. It features three temperature scales.
o 2°C to 8°C used as a pharmacy refrigerator.
o -10°C to -25°C used as a deep freezer.
o 22 ± 2°C used as an incubator.
• -40°C Medical Freezer comes in an ergonomic design with a built-in lock. It can allow temperature adjustments in the range of -20°C and -40°C to store vaccines, blood plasma and many other biological materials.
• -25°C Deep Freezer comes with a digital display temperature setting with a temperature range of -10°C to -25°C.
• 2° to 8°C Pharmacy Refrigerators comes with an ergonomic design that guarantees a constant cabinet temperature of 2°C to 8°C. These refrigerators have an integrated high-tech sensor to display and control the temperature. A built-in battery backup with audible and visual alarm systems works for up to 72 hours without AC source power. They are suitable for blood banks, hospitals and centers for disease control and prevention.
