B Medical Systems’ U201 receives the world’s first WHO PQS prequalification for Ultra-Low Freezers


3rd March 2022, India: B Medical Systems, a global leader in medical cold chain solutions, has announced that the company’s Ultra-Low Freezer U201 has received the WHO PQS prequalification. This is the first-ever Ultra-Low Freezer in the world to receive the WHO  PQS prequalification.  

Ultra-Low Freezers are used for storing temperature-sensitive specimens, biosamples,  vaccines, etc., at temperatures as low as -86°C to enable their long-term and reliable storage. The WHO Performance, Quality, and Safety (PQS) process prequalifies products and devices  so that member states and UN purchasing agencies are assured of their suitability for use in  immunization programs. 

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The U201 has a gross storage volume of 214L and provides a storage temperature varying from  -86°C to -20°C. Designed with state-of-the-art refrigeration technology, the product offers  superior temperature uniformity and holdover time. U201 uses a green refrigerant that has  minimal impact on the environment and is compliant with the US SNAP and EU F-Gas  regulations. The unit offers advanced inbuilt alarm systems and provides 24/7 real-time  monitoring solutions via the company’s Real-Time Monitoring Devices (RTMD) and °B  Connected solution. The password-protected/NFC-based locking mechanism further prevents  unauthorized access to the specimens. The product is certified to operate at ambient  temperature as high as +43°C and is an ideal solution for last-mile vaccination campaigns,  doctor’s clinics, hospitals, etc. The U201 is also a class II(a)/II certified medical device as per  EU MDR and US FDA regulation. 

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Mr. Luc Provost, CEO of B Medical Systems said, “It’s a very proud moment for us. The WHO  PQS prequalification is a testament to the quality and standard of our product. The U201  Ultra-Low Freezer offers a compact, reliable, and, sustainable ultra-low freezing solution. The  unit can work at ambient temperatures as high as 43°C, making it a perfect solution to be used  even in areas with harsh tropical climates. We developed this product to meet the growing  demand for ultra-low temperature storage of COVID-19 vaccines. However, with the growth  of mRNA technology, cell and gene therapy, etc, we see more and more requirements for  reliable ultra-low temperature storage across the world’’ 

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About B Medical Systems:  

B Medical Systems S.a r.l is a global manufacturer and distributor of vaccine cold chain and medical  refrigeration solutions. Across the 3 major business portfolios of Vaccine Cold Chain, Medical  Refrigeration, and Blood Management solutions, the company offers 100+ products. B Medical  Systems’ major products include Vaccine Refrigerators (Ice-Lined and Solar Direct Drive Refrigerators  (SDD)), Laboratory Refrigerators, Blood Bank Refrigerators, Laboratory Freezers, Pharmacy  Refrigerators, Ultra-Low Freezers, and Transport boxes. All products have integrated 24/7 remote  monitoring capabilities that further ensure that these products offer the highest level of safety and  reliability. B Medical Systems’ products are used across 140+ countries and have an installed base of  more than 500,000 products across the world. B Medical Systems has subsidiaries in the USA and India.

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