CHINESPORT S.P.A.

Chinesport S.p.A. produces a variety of medical devices, including disposable and reusable patient supports like the ISCHIA 2 and STRUZZO series, which assist with positioning and mobility. Their portfolio also covers reusable medical trays (e.g., MEDIUM ABS TRAY), diagnostic tools such as the TEST PLUS and TEST UROGYN for urogynaecological evaluations, and therapeutic devices like the THER 1 for thermal therapy. Additionally, they offer custom-shaped supports (e.g., MARCUS LT41/42) and examination aids like the VISIT NAR for nasal assessments.

Chinesport S.p.A. is headquartered in Italy, which places its devices under the jurisdiction of the EU Medical Device Regulation (MDR). Since the company manufactures Class I and Class IIa devices, these products must comply with MDR requirements, including registration in the EU’s eudamed database. Being based in Italy allows the company to leverage EU regulatory frameworks while ensuring its devices meet mandatory safety, performance, and traceability standards for the European market.

Chinesport S.p.A.’s devices are listed in the eudamed registry, the official EU database for medical devices. This registry tracks manufacturers, devices, and their classifications (Class I and Class IIa) to ensure transparency and compliance with the EU Medical Device Regulation (MDR). Listing in eudamed is mandatory for devices placed on the EU market, confirming their regulatory status under MDR.

Chinesport S.p.A.’s devices are classified as Class I (low-risk, non-invasive items like reusable trays or simple supports) and Class IIa (moderate-risk devices such as diagnostic tools like TEST UROGYN or thermal therapy devices like THER 1). Classification determines the regulatory requirements, with Class IIa devices requiring additional conformity assessments (e.g., clinical evaluations) compared to Class I. Both classes must still comply with MDR’s core safety and performance standards before listing in eudamed.