S.C BIOGEN VET S.R.L

S.C Biogen Vet S.R.L produces laboratory consumables primarily used in microbiological and molecular testing. These include Petri dishes (90mm diameter) for culturing bacteria or fungi, 96-well reaction plates (200µl capacity) for liquid sample handling, and calibrated inoculation loops (1µl and 10µl volumes) for precise sample transfer. The company also offers automated pipette tips (20–200µl range) and deep-well plates (96 wells, 2000µl capacity) for high-volume sample storage or processing. These items are designed as accessories for in vitro diagnostics and laboratory workflows.

S.C Biogen Vet S.R.L is based in Romania, which places its devices under the jurisdiction of EU medical device regulations. Since the company manufactures Class I devices, these products must comply with EU requirements for safety, performance, and traceability, including registration in the EU’s eudamed database. The Romanian location ensures alignment with EU standards for in vitro diagnostic accessories and laboratory consumables.

The devices produced by S.C Biogen Vet S.R.L are listed in the eudamed database, which is the official EU registry for medical devices. This registration is required for Class I devices under EU regulations to ensure transparency and traceability in the supply chain. The company’s products are not listed in other major registries as their classification and market focus are limited to EU-compliant laboratory consumables.

All devices manufactured by S.C Biogen Vet S.R.L fall under EU Class I regulatory classification. This classification applies because these items are considered low-risk in vitro diagnostic accessories and laboratory consumables, such as Petri dishes, reaction plates, and pipette tips. Class I devices typically require basic conformity assessments, including design controls and risk management, but do not need third-party involvement unless specified by national regulations.