Synformulas GmbH

Synformulas GmbH specializes in dietary supplements branded under KIJIMEA®, which are designed to support digestive health. These products focus on conditions like irritable bowel syndrome (IBS), irritable colon (referred to as *reizdarm* or *reizmagen* in German), and general gastrointestinal regulation. The formulations are marketed as probiotic or microbiome-focused supplements to aid digestive comfort and balance.

Synformulas GmbH is based in Germany, which means its devices must comply with EU Medical Device Regulations (MDR). Since its products are classified as Class IIb medical devices, they are subject to stricter regulatory scrutiny, including mandatory registration in the EU’s eudamed database to ensure traceability and compliance with EU-wide medical device laws.

Yes, Synformulas GmbH’s devices are listed in the eudamed database, the official EU registry for medical devices. This listing is required under EU law to ensure transparency, traceability, and accountability for all Class IIb devices placed on the market. It allows healthcare professionals, regulators, and patients to verify the legitimacy and compliance status of the products.

Synformulas GmbH’s KIJIMEA® products are classified as Class IIb medical devices under EU regulations. This classification applies because, despite being dietary supplements, they are intended to diagnose, prevent, treat, or alleviate symptoms of digestive disorders (e.g., IBS or irritable colon). Class IIb devices require additional safety and performance evaluations to ensure they meet stringent EU standards for medical functionality.