Hitec Medical MDR kudzidziswa - Tsanangudzo yeMDR Matemu

Chigadzirwa chekurapa

Zvinoreva chero chiridzwa, mudziyo, mudziyo, software, implant, reagent, zvinhu, kana chimwe chinhu chinoshandiswa chete kana musanganiswa nemugadziri kune chimwe kana zvimwe zvinangwa zvekurapa mumuviri wemunhu.

• Kuongororwa, kudzivirira, kutarisa, kufanotaura, kufungidzira, kurapwa kana kuregererwa kwezvirwere;
• Kuongororwa, kutarisa, kurapwa, kuregererwa, uye kubhadharwa kwekukuvara kana kuremara;
• Kudzidza, kutsiva, uye kudzora anatomical, physiological, kana pathological maitiro kana nyika;
• Ipa ruzivo kuburikidza ne in vitro bvunzo yemasampuli kubva mumuviri wemunhu, kusanganisira nhengo, ropa, uye nyama dzakapihwa;
• Kushandiswa kwaro kunonyanya kuwanikwa kuburikidza nemuviri uye nedzimwe nzira, kwete kuburikidza nemishonga, immunology, kana metabolism, kana kunyange zvazvo nzira idzi dzichibatanidzwa, dzinongotamba basa rekubatsira;
• Zvishandiso zvine kudzora kana zvinangwa zvekutsigira
• Kunyanya kushandiswa kuchenesa, kuuraya utachiona, kana sterilizing zviridzwa.

Active mudziyo

Chero mudziyo unoshanda sesosi yesimba kunze kwekuvimba nemuviri wemunhu kana giravhiti, uye unoshanda nekushandura density yesimba kana kushandura simba.Zvishandiso zvinoshandiswa kufambisa simba, zvinhu, kana zvimwe zvinhu pakati pezvishandiso zvinoshanda nevarwere pasina shanduko yakakosha hazvizotorwa sezvishandiso zvinoshanda.

Invasive device

Chero mudziyo unopinda mukati memuviri wemunhu kuburikidza nemakwara chaiwo kana nzvimbo.

Procedure pack

Musanganiswa wezvigadzirwa zvakaputirwa pamwechete uye zvinotengeswa nechinangwa chekurapa.

Mugadziri

Munhu wenyama kana wepamutemo anogadzira kana kugadziridza zvizere mudziyo kana mudziyo wakagadzirwa, wakagadzirwa, kana wakagadziridzwa zvizere uye anotengesa mudziyo pasi pezita kana chiratidzo chekutengeserana.

Kugadzirisa zvizere

Zvichienderana netsanangudzo yemugadziri, zvinoreva kugadziridzwa kwakazara kwemidziyo yakaiswa pamusika kana kuiswa mukushandiswa, kana kushandiswa kwemidziyo yakashandiswa kugadzira michina mitsva inoenderana nemutemo uyu uye kupa michina yakagadziridzwa hupenyu hutsva. 

Authorized Representative

Chero munhu wechisikigo kana wepamutemo anoonekwa mukati meEU anogashira uye anogashira mvumo yakanyorwa kubva kumugadziri ari kunze kweEU kuti atore zviito zvese achimiririra mugadziri zvinoenderana nezvisungo zvakaiswa neMutemo uyu pamugadziri.

Importer

Chero munhu wechisikigo kana wepamutemo anozivikanwa mukati meEuropean Union anoisa zvishandiso kubva kunyika dzechitatu pamusika weEU.

Distributors

Chero munhu wechisikigo kana wepamutemo mune mutengesi, kunze kwemugadziri kana mutengesi, anogona kuisa mudziyo pamusika kusvika washandiswa.

Unique Device Identification (UDI)

Mutsara wenhamba kana alphanumeric mavara akagadzirwa kuburikidza nepasirese ziviso yemidziyo inozivikanwa pasi rose uye macoding standards, zvichibvumira kuzivikanwa kwakajeka kwemidziyo chaiyo pamusika.