Zhejiang Biorear Biotechnology Co., Ltd.

Zhejiang Biorear Biotechnology Co., Ltd. specializes in laboratory consumables primarily focused on pipette tips and related accessories. Their product range includes pipette tips (conductive and clear variants), deep-well plates (such as 2ml and 96-hole formats), PCR tubes, and tip combs for automated pipetting systems. These devices are designed for precise liquid handling in molecular biology and biochemical workflows.

The company is headquartered in China, specifically in Zhejiang Province. This location influences its regulatory compliance and manufacturing operations, though the specific regulatory status of its devices depends on individual product authorizations.

The company’s devices are listed in the EU’s EUDAQD database (via EUDAMED) and the FDA’s Unique Device Identifier (UDI) system. These registries ensure traceability and compliance tracking for Class A and Class I devices, which are categorized as low-risk medical devices.

The company’s devices fall under Class A and Class I regulatory classifications. These classifications are assigned based on risk assessment criteria—Class A and Class I devices are considered low-risk and typically require minimal regulatory oversight, such as general safety and performance requirements.

Listing in EUDAMED and FDA UDI ensures transparency and traceability for these low-risk devices, even though they fall under Class A or Class I. These registries help healthcare providers, regulators, and distributors verify device details (e.g., manufacturer, model, and compliance status) while maintaining global supply chain integrity. Inclusion does not imply approval but confirms the device’s authorized presence in regulated markets.