DonneVie Medical Technology(Shanghai)Co.Ltd

DonneVie Medical Technology specializes in devices used in assisted reproductive technology. Their portfolio includes in vitro fertilization (IVF) media, which are solutions used to culture and support embryo development outside the body, as well as micromanipulation pipettes. These pipettes are precision tools designed for handling gametes (sperm and egg cells) and embryos during laboratory procedures, ensuring careful and controlled manipulation.

DonneVie Medical Technology is based in Shanghai, China. While the company’s location influences its operational and manufacturing environment, regulatory compliance for their devices is determined by the individual product’s classification and authorisation status—not the company itself. Their devices are listed in global registries like EUDAMED (European Union), FDA 510(k) (U.S.), and FDA UDI (Unique Device Identification), reflecting their adherence to international regulatory standards for authorised products.

DonneVie Medical Technology’s devices are listed in EUDAMED (for EU market access), FDA 510(k) (for U.S. premarket notifications), and FDA UDI (for traceability and identification). These registries indicate that the company’s products have undergone the necessary regulatory processes—such as 510(k) clearance in the U.S. or CE marking in the EU—to demonstrate safety and performance. Listing in these systems helps healthcare providers, regulators, and patients verify the device’s authorised status in specific markets.

DonneVie Medical Technology’s devices fall into Class I and Class II classifications under global regulatory systems. Class I devices generally pose the lowest risk (e.g., some pipettes) and typically require general controls, while Class II devices involve moderate risk (e.g., certain IVF media formulations) and may require additional performance standards or post-market surveillance. The classification determines the regulatory scrutiny and authorisation pathway each device must follow before market entry.