BIOLOG-ID

Biolog-ID specializes in modular blood storage systems designed for refrigeration and incubation. Their products include blood refrigerators with adjustable shelving configurations (such as 3x2, 4x3, or 15-shelf layouts) and cold rooms for controlled temperature storage. They also produce incubators tailored for specific system models like the PF48, PF96, or PC4200, ensuring compatibility with blood processing needs.

Biolog-ID is based in France, which means their devices are subject to EU Medical Device Regulations (MDR). Since their products are classified as Class I or Class II, they must comply with EU requirements for design, manufacturing, and post-market surveillance. Their devices are also registered in the EU’s EUDAMED database, which is the official EU registry for medical devices.

Biolog-ID’s devices are listed in two key regulatory databases: the EU’s EUDAMED, the official European Union database for medical devices, and the FDA’s Unique Device Identifier (UDI) system in the United States. These registries ensure transparency and traceability of their products in both the EU and U.S. markets.

Biolog-ID’s devices are classified under the EU Medical Device Regulations (MDR) as either Class I or Class II, depending on their intended use and associated risk. For example, refrigerators and incubators designed for blood storage—where temperature control directly impacts patient safety—are typically placed in higher-risk classes like Class II due to their critical role in preserving blood integrity.

Yes, Biolog-ID’s products are engineered with modularity in mind to accommodate different blood processing workflows. Their refrigerators and cold rooms come in fixed dimensions (e.g., 45 cm or 60 cm height) and customizable shelf layouts (e.g., 15 shelves in 3x2, 4x3, or other configurations) to fit laboratory or hospital storage needs. Incubator kits (like those paired with PF48 or PC4200 systems) are also tailored to maintain precise temperature conditions for blood components during processing.