Kipuwex and Bep­sun Achieve Chi­nese NMPA Approval, Paving the Way for Mar­ket Expan­sion

Kipuwex AB, a lead­ing inno­va­tor in remote health mon­i­tor­ing solu­tions, in col­lab­o­ra­tion with Chi­nese part­ner Bep­sun, has obtained approval from the Nation­al Med­ical Prod­ucts Admin­is­tra­tion (NMPA), Chi­na’s equiv­a­lent of the FDA. This sig­nif­i­cant mile­stone autho­rizes the dis­tri­b­u­tion and use of Kipuwex’s advanced remote mon­i­tor­ing tech­nol­o­gy with­in the Chi­nese health­care sys­tem, under the brand name Iso­gang.

Kipuwex’s ear­ly-stage investor and strate­gic part­ner, Bep­sun Eurotech Solu­tion Oy, has already secured the Class II NMPA med­ical device cer­ti­fi­ca­tion for the Chi­na-spe­cif­ic imple­men­ta­tion of Kipuwex tech­nol­o­gy. Its affil­i­at­ed man­u­fac­tur­ing enti­ty, based in Hunan, Chi­na, holds the cer­tifi­cate. The prod­uct is expect­ed to enter pro­duc­tion and sales in the Chi­nese mar­ket in the near future.

This approval marks a piv­otal step in Kipuwex’s mis­sion to enhance patient care glob­al­ly. With Chi­na’s vast and dynam­ic health­care land­scape, the NMPA cer­ti­fi­ca­tion enables Kipuwex to intro­duce its non-inva­sive, real-time mon­i­tor­ing tech­nol­o­gy to a broad­er audi­ence, address­ing crit­i­cal needs in patient mon­i­tor­ing.

Bep­sun, renowned for its exper­tise in med­ical device dis­tri­b­u­tion with­in Chi­na, will spear­head the intro­duc­tion of Kipuwex’s tech­nol­o­gy across hos­pi­tals and clin­ics nation­wide. This col­lab­o­ra­tion ensures that health­care providers in Chi­na will have access to advanced tools for con­tin­u­ous patient mon­i­tor­ing, ulti­mate­ly enhanc­ing the qual­i­ty of care.

The Kipuwex tech­nol­o­gy offers a com­pact, wire­less solu­tion for mon­i­tor­ing vital signs such as ECG, heart rate, and res­pi­ra­to­ry rate. Its user-friend­ly inter­face and real-time data trans­mis­sion capa­bil­i­ties make it an invalu­able asset for health­care pro­fes­sion­als seek­ing to opti­mize patient care.

Con­tact per­son
Tit­ta Kuis­ma-Höynälä
Chief Mar­ket­ing Offi­cer, Kipuwex
titta.kuisma@kipuwex.com

Source: Kipuwex
In the pic­ture: Marko Höynälä and Hongjin Zhang