Isirinji yoKhuseleko oluVunyelweyo lwezonyango oluVunyelweyo oluVunyelweyo yiCe/FDA ukuze kukhuselwe uMongikazi kunye nezigulana
Iisirinji zokhuseleko ezirhoxayo ngokuzenzekelayo zisetyenziswa rhoqo kwizibhedlele, kwiikliniki, nakwezinye iindawo zonyango kwiinkqubo ezahlukeneyo zonyango, kubandakanya ukunika amayeza, ukutsala igazi, kunye nokufaka inaliti, konke oku kunciphisa umngcipheko wokwenzakala kwenaliti kunye nosulelo.
Iisirinji zokhuseleko ezirhoxayo ngokuzenzekelayo zizixhobo zonyango ezintsha ezenzelwe ukuphucula ukhuseleko ngexesha lokujova kunye nokukhusela iingcali zempilo kunye nezigulana ekwenzakaleni ngenaliti.
| Uhlobo lwesirinji | Isiraphu yoKhuseleko eLahlwayo yoNyango |
| Umqulu | 1mL, 2mL (2.5mL), 3mL, 5mL, 10mL, 20mL, 30mL, 50mL, 60mL. |
| Ukucoca nge-ethylene Oxide | Ewe |
| Isiqinisekiso | I-CE, i-FDA, i-ISO13485 |
| Isampulu | Mahala (iintsuku ezisi-7-10) |
| Iphakheji | Ukupakisha iBlister okanye iPE |
| Iintsuku zokuhanjiswa | Iintsuku ezili-15-20 |
| Impumlo | Impumlo esembindini okanye impumlo esecaleni |
| Uhlobo lwe-plunger | Ecacileyo, emhlophe, eluhlaza okwesibhakabhaka, emthubi |
| Umgqomo | Ecacileyo |
| I-OEM/ODM | Yamkelekile |
Iimbonakalo:
1. Ukurhoxiswa Kwenaliti Ngokuzenzekelayo: Uphawu oluphambili kukurhoxiswa kwenaliti ngokuzenzekelayo kwibharele yesirinji emva kokuba inaliti igqityiwe.
2. Uyilo Olulula Ukulisebenzisa: Iisirinji ezirhoxayo ngokuzenzekelayo zenzelwe ukuba zisebenziseke lula kwaye zibe nobuchule.
3. Ukusebenza Ngesandla Esinye: Olu phawu luvumela ukugonywa okulula nokusebenzayo, ingakumbi kwiindawo ezixakekileyo zempilo.
4. Ukuthintela Ukulimala Ngenaliti: Oku kubaluleke kakhulu kubasebenzi bezempilo abasoloko befaka iinaliti kwaye basengozini enkulu yokwenzakala okunjalo.
CE
I-ISO13485
I-USA FDA 510K
EN ISO 13485 : 2016/AC: 2016 Inkqubo yolawulo lomgangatho wezixhobo zonyango ngokweemfuno zomthetho
I-EN ISO 14971: Izixhobo zonyango zika-2012 - Ukusetyenziswa kolawulo lomngcipheko kwizixhobo zonyango
I-ISO 11135:2014 Izixhobo zonyango Ukucoca i-ethylene oxide Ukuqinisekiswa kunye nolawulo ngokubanzi
I-ISO 6009:2016 Iinaliti zokujova ezingafunekiyo nezilahlwayo Chonga ikhowudi yombala
I-ISO 7864:2016 Iinaliti zokujova ezingasetyenziswanga nezingenazintsholongwane
I-ISO 9626:2016 Iityhubhu zeenaliti zentsimbi engenasici zokwenza izixhobo zonyango
I-SHANGHAI TEAMSTAND CORPORATION ngumboneleli ophambili weemveliso zonyango kunye nezisombululo.
Ngamava angaphezu kweminyaka eli-10 okubonelela ngeenkonzo zempilo, sinikezela ngokukhetha iimveliso ezahlukeneyo, amaxabiso akhuphisanayo, iinkonzo ze-OEM ezibalaseleyo, kunye nokuhanjiswa okuthembekileyo ngexesha elifanelekileyo. Besingumthengisi weSebe lezeMpilo likaRhulumente wase-Australia (AGDH) kunye neSebe lezeMpilo likaRhulumente laseCalifornia (CDPH). E-China, siphakathi kwababoneleli abaphezulu be-Infusion, Injection, Vascular Access, Rehabilitation Equipment, Hemodialysis, Biopsy Needle kunye neemveliso zeParacentesis.
Ngowama-2023, besisele siphumelele ekuhambiseni iimveliso kubathengi kumazwe angaphezu kwe-120, kuquka i-USA, i-EU, i-Middle East, kunye ne-Southeast Asia. Izenzo zethu zemihla ngemihla zibonisa ukuzinikela kwethu kunye nokuphendula kwiimfuno zabathengi, nto leyo esenza sibe liqabane leshishini elithembekileyo nelidibeneyo elikhethwayo.
Sifumene udumo oluhle phakathi kwaba bathengi ngenxa yenkonzo entle kunye namaxabiso afikelelekayo.
A1: Sinamava eminyaka eli-10 kweli candelo, Inkampani yethu ineqela leengcali kunye nomgca wemveliso yobungcali.
A2. Iimveliso zethu ezikumgangatho ophezulu kunye nexabiso elikhuphisanayo.
A3. Ngokwesiqhelo yi-10000pcs; singathanda ukusebenzisana nawe, ungakhathazeki malunga ne-MOQ, sithumelele nje izinto zakho ofuna ukuziodola.
A4. Ewe, ukwenziwa ngokwezifiso kweLOGO kuyamkelwa.
A5: Ngokwesiqhelo sigcina uninzi lweemveliso esitokhweni, singathumela iisampulu kwiintsuku ezi-5-10 zomsebenzi.
A6: Sithumela nge-FEDEX.UPS, DHL, EMS okanye eLwandle.
Yintoni isirinji yokhuseleko-TEAMSTAND
Iingozi zonyango ezinxulumene neenaliti eziqhelekileyo azikho ngaphantsi kwezo zinxulumene neesirinji. Iinkampani zasekhaya nakwamanye amazwe ziye zazama ngamandla ukujova ngokukhuselekileyo kuphando nophuhliso lwezixhobo zonyango, kodwa kukho izixhobo ezininzi zokujova ezikhuselekileyo ezikhoyo kwimarike: enye yindleko ephezulu yemveliso, enye yinkqubo yemveliso enzima; eyesithathu kukuba umgangatho wemveliso kunzima ukuwuqinisekisa; eyesine, abasebenzi bezonyango abadinisayo; ezintlanu kunzima ukuqinisekisa ukusebenza ngokukhuselekileyo. Ukongeza, inaliti yokujova iqinile kakhulu ngenxa yezizathu ezibalulekileyo kwinkqubo yokurhoxa. [0004] Ke ngoko, uphuhliso lwenaliti yokujova yokhuseleko lokurhoxa elahlwayo lubaluleke kakhulu kwaye ixesha elide ekuphuhliseni inaliti yokujova yokhuseleko elahlwayo elahlwayo. Ke ngoko, isirinji ekhuselekileyo ibaluleke kakhulu. Singakunika iinkonzo ezikumgangatho ophezulu kunye nomgangatho ophezulu.iisirinji ezikhuselekileyoisirinji yenaliti yokhuselekoIsirinji erhoxayoYicime ngokuzenzekelayo i-syringe
