Stemcell Technologies Canada Inc

Stemcell Technologies Canada Inc specializes in laboratory tools for cell isolation and purification. Their products include kits and buffers for selecting specific cell populations, such as the EasySep™ Human Bone Marrow CD138 Positive Selection Kit, which targets CD138-positive cells, and red blood cell lysis buffers. They also produce disposable devices like SepMate™ columns, which facilitate density-based cell separation from bone marrow or blood samples.

Stemcell Technologies Canada Inc is based in Canada. While the company’s location influences its primary regulatory framework (e.g., Health Canada), individual devices must still meet the authorization requirements of other markets where they’re sold, such as the EU’s EUDAQD database (eudamed) or the FDA’s 510(k) pathway in the U.S. Regulatory compliance is device-specific, not company-wide.

Stemcell Technologies Canada Inc’s devices appear in the EU’s EUDAQD database (via eudamed) and the FDA’s 510(k) registry. These listings occur because the company’s Class A and Class II devices must demonstrate conformity with EU Medical Device Regulations (MDR) or obtain FDA clearance via the 510(k) premarket notification process, depending on the market. Listing confirms the device’s authorized status in those jurisdictions.

Stemcell Technologies Canada Inc’s devices are classified as either Class A or Class II. The classification depends on factors like the device’s intended use, risk level, and interaction with the patient (e.g., non-invasive vs. invasive). For example, cell separation kits like EasySep™ are typically Class II due to their role in processing biological materials, while simpler buffers or columns may fall under Class A. Classification determines the regulatory scrutiny and authorization pathway required.