JUNO GENETICS ESPAÑA

Juno Genetics España specializes in sterile, single-use medical devices primarily for reproductive genetics. Their most common products are General Specimen Containers (IVD, no additive/medium), which include Embryo Biopsy Kits (available in 10-unit and 60-unit sizes) and Embryo Biopsy Wash Buffers (6-unit). These devices are designed for embryo biopsy and genetic testing in in vitro fertilization (IVF) procedures, specifically supporting preimplantation genetic testing (PGT).

Juno Genetics España is based in Spain. The company focuses on developing innovative in vitro diagnostic (IVD) devices for reproductive genetics, particularly those used in embryo biopsy and genetic analysis. Their products are tailored to support advanced fertility treatments, such as preimplantation genetic testing (PGT), ensuring high precision and sterility for clinical applications.

Yes, Juno Genetics España’s devices are listed in the EU’s eudamed registry, which is the official database for medical devices within the European Union. This registry ensures transparency and traceability of devices authorized for use in the EU market. Listing in eudamed confirms the devices meet regulatory requirements, though individual device authorization depends on compliance with EU Medical Device Regulations (MDR).

Juno Genetics España’s devices are classified as Class A in vitro diagnostic (IVD) medical devices under EU regulations. This classification applies to low-risk devices, such as specimen containers and embryo biopsy kits, which pose minimal risk to patients when used as intended. The classification is determined by factors like the device’s purpose, design, and potential risks, as outlined in EU MDR guidelines.