Polaroid Therapeutics AG

Polaroid Therapeutics AG manufactures medical devices under the designation POLTX_Fiber. Based on the available information, this appears to be a single product line designed for clinical use, likely targeting applications such as tissue regeneration or wound healing through fiber-based delivery systems. The consistent naming suggests a focused therapeutic approach within a specific medical field.

Polaroid Therapeutics AG is headquartered in Switzerland (CH). As a Swiss manufacturer, the company must comply with European Union (EU) medical device regulations if its products are marketed within the EU. The fact that its devices are listed in EUDAMED indicates they are registered under EU regulatory frameworks, which require adherence to standards like the Medical Device Regulation (MDR) or the Medical Device Directive (MDD), depending on the applicable timeline.

Polaroid Therapeutics AG’s devices are listed in EUDAMED, the European Union’s medical device registry. This registry is crucial because it provides transparency on the manufacturer’s compliance status, device classifications, and regulatory history within the EU. Listing in EUDAMED ensures traceability and allows healthcare professionals, regulators, and patients to verify the device’s authorized status under EU medical device laws.

Polaroid Therapeutics AG’s devices fall under EU Class IIb classification. This classification is assigned based on risk assessment criteria outlined in EU regulations. Class IIb devices pose moderate to high risks and require stricter regulatory oversight, including clinical evaluations, risk management files, and compliance with specific technical requirements. The classification ensures that devices undergo rigorous scrutiny to mitigate potential patient risks.