fusion2025/10/27
                                      
Meling Biomedical, as a leading innovator in the medical device sector, recently announced that its flagship product, -80℃ ULT freezers , -40℃ ULT freezers and blood bank refrigerators ], has successfully received certification under the European Union’s Medical Device Regulation (MDR). This significant milestone underscores the company's unwavering commitment to the highest standards of clinical safety, performance, and quality for patients and healthcare providers across Europe.

 

The MDR (EU 2017/745) represents the most stringent regulatory framework for medical devices in the world, demanding enhanced clinical evidence, rigorous post-market surveillance, and greater transparency. Achieving the new standard MDR certification for several series ultra-low temperature freezers and blood bank refrigerators are a testament to the product's robust design, clinical efficacy, and the company's diligent quality management system.
Unlcock Meling Biomedical MDR Certification Approved Products

Meling Biomedical frequency conversion dual cooling system ULT Freezer, which built up by two independent refrigeration systems and the dual cooling system offers the highest level of protection, only one single system work independently can maintain the freezer around the -80℃, valuable and irreplaceable samples can always be securely stored with the highest confidence even if the compressor fails.

*Frequency Conversion Cascade ULT Freezer

Meling Biomedical Frequency Conversion Cascade ULT freezer that consists of two stages cascade cooling technology with absolute hydrocarbon refrigerant, which are R290 and R170 as natural gas. The inverter compressors programmed to help energy savings under long period preservation or provide fast temperature recovery while frequently door open to maintain specimens liveness. The two-stage inverter technology compressor systems with adaptive control is designed to detect high and low usage patterns, adjust compressor speeds, and reduce energy, first stage is cooled down to -45℃ then, during the second stage, cooled down from -45℃ to -86℃. This enables smooth and reliable operation of the individual compressors as they work in a comfort zone.

*-86℃ Target Cooling ULT Freezer

Meling Biomedical Target Cooling ULT freezer that consists of auto cascade cooling technology with nature hydrocarbon refrigerant. It offers high level of protection, refrigeration system in parallel provide dual cooling compressors ensure fast pulling down and door open recovery time, and if one of compressors in system get broken in case,the another compressor can continue working to maintain the temperature at -70℃,to save up the samples inside chamber.

 

Meling Biomedical blood bank refrigerators are engineered to meet the stringent requirements of blood banks and healthcare facilities. With advanced temperature control technology and reliable performance, provide the ideal environment for storing blood products. They are designed with a uniform cooling system. This advanced design allows for the even distribution of cold air throughout the storage chamber, the temperature uniformity reaches≤±1℃, effectively preserving the integrity of blood products. To effectively accommodate a diverse range of blood products in varying sizes and quantities, the refrigerator is equipped with versatile adjustable shelving options. This thoughtful design flexibility facilitates customized storage configurations, thereby optimizing space utilization within the unit. 
The -40℃ ULT freezer meets long terms of sample storage demands under powerful compressor, CFC-Free foaming with inner door kit build hard barrier against heat loss. And the high-precision microcomputer temperature control system has the ability to set the temperature inside the cabinet in the range of -20°C ~-40°C. It is intended for cryopreservation of plasma, cells, tissues, etc, and is applicable to blood stations, hospitals, epidemic prevention stations, research institutes etc.
The successful MDR certification is not just a regulatory milestone; it validates our mission to deliver safe, effective, and cutting-edge medical solutions.This accomplishment reinforces our position as a trusted partner in the global healthcare ecosystem.It also paves the way for future innovations under the robust MDR framework.

At Meling Biomedical, we are pushing the boundaries of medical technology. Grounded in an unwavering commitment to patient safety and regulatory compliance, we accelerate innovation to empower the future of global healthcare and research.

Sailing off for the life sciences!

 

 

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