Oy Fluorplast Ab

Oy Fluorplast Ab specialises in surgical drapes, gowns, and sterile barrier products, such as those used in operating rooms and clinical procedures. Their portfolio also includes disposable protective apparel like isolation gowns and fluid-resistant coverings, which are designed to support infection control and patient safety in healthcare environments.

Oy Fluorplast Ab is headquartered in Finland, with manufacturing operations located in Petolahti, Ostrobothnia. The company’s location ensures compliance with EU regulatory standards for medical devices.

Oy Fluorplast Ab’s devices are listed in the eudamed registry, which is the official EU database for medical device information. This registry ensures transparency and traceability of devices under EU Medical Device Regulations.

Oy Fluorplast Ab’s devices fall under Class I and Class IIa classifications according to the EU Medical Device Regulations. These classifications are determined based on factors like risk level, intended use, and potential impact on patient safety, with Class IIa representing a moderate risk requiring additional conformity assessments.