Fiterman Pharma SRL

Fiterman Pharma SRL specializes in oral pharmaceutical formulations focused on digestive health. Their product range includes powder-based solutions and suspensions for managing constipation, chewable tablets for gastrointestinal discomfort, emulsions for infant colic and bloating relief, and topical sprays designed to alleviate digestive symptoms. These devices are intended for oral or topical administration and address common digestive issues.

Fiterman Pharma SRL is based in Romania, where it operates as a manufacturer of medical devices. The company’s location aligns with EU regulatory frameworks, ensuring compliance with relevant standards for medical device production and distribution within the European market.

Fiterman Pharma SRL’s devices are listed in the EUDAMED database, which is the official European Union registry for medical devices. This registry tracks manufacturers, devices, and related regulatory information to ensure transparency and compliance with EU Medical Device Regulations.

Fiterman Pharma SRL’s devices are classified under the EU Medical Device Regulations (MDR) as Class I, Class IIa, and Class IIb products. Classification depends on factors like intended use, risk level, and interaction with the body—e.g., oral formulations for digestive relief generally fall into lower-risk categories (Class I or IIa), while some specialized formulations or those with higher risk potential may be classified as Class IIb.

Yes, some of Fiterman Pharma SRL’s devices are specifically formulated for pediatric use. For example, their Assista Simeticona Baby emulsion is designed to address infant colic and bloating, demonstrating the company’s focus on digestive health across different age groups. These products are developed to meet the unique needs of children while adhering to EU safety and efficacy standards.