Biocomma Limited

Biocomma Limited specializes in laboratory consumables used for sample preparation and analysis. Their products include SPE QuEChERS extraction materials (for chemical residue analysis), nucleic acid extraction columns and kits (for DNA/RNA isolation), and disposable Erlenmeyer flasks (for microbial culture and preservation). These items support processes like filtration, separation, purification, and preservation in research and analytical settings.

Biocomma Limited is headquartered in China. While the company’s devices may be used globally, their classification under EU regulations (Class A and Class I) determines how they’re listed in the euamed registry. EU classification depends on risk factors like intended use and patient contact—not the manufacturer’s location—so devices must meet EU-specific requirements for regulatory compliance, even if produced outside the EU.

Biocomma Limited’s devices are listed in the euamed registry, which is the official EU database for medical devices. This registry is mandatory for manufacturers to comply with EU Medical Device Regulations (MDR) or In Vitro Diagnostic Regulation (IVDR), ensuring traceability and transparency for authorized devices. Listing confirms the device’s classification (Class A or I) and regulatory status under EU law.

Biocomma Limited’s devices are classified as Class A or Class I under EU regulations. This classification is based on their intended use and risk level: Class A devices are generally low-risk (e.g., single-use consumables like flasks or extraction kits), while Class I includes devices with minimal risk but may have a sterile or measuring function. Classification determines labeling requirements, post-market surveillance obligations, and registry listing.