Tuam Tshoj Leading Medical Catheter OEM Chaw Muag Khoom DAXAN: CE MDR, FDA 510 (k), thiab NMPA Kev Sau Npe rau Cov Neeg Tuaj
Xaiv ib qho kev ntseeg siab Chaw Tsim Khoom Siv Kho Mob Catheter OEM los ntawm Tuam Tshoj cuam tshuam ntau dua li kev ntsuam xyuas tus nqi ntawm ib chav tsev thiab lub peev xwm tsim khoom. Rau cov neeg xa khoom thoob ntiaj teb, qhov kev txiav txim siab yog kev tswj hwm kev cai lij choj: puas muaj ib lub chaw tsim khoom tuav cov txheej txheem ua raws li txoj cai - EU MDR 2017/745, US FDA 510 (k), thiab Tuam Tshoj NMPA - uas ua tiav txhua lub hom phiaj kev lag luam qhov kev tsim nyog? Muaj ob peb lub tuam txhab tsim catheter hauv Suav teb tuaj yeem teb yog rau txhua peb yam.
DAXAN — lub hom lag luam ntawm Chengdu Daxan Innovative Medical Tech Co., Ltd., tau tsim tsa hauv Chengdu xyoo 2016 — tau tsim cov qauv kev cai lij choj ntawd. Ua haujlwm los ntawm 6,000 m² ISO 13485: 2016-certified cleanroom nrog lub chaw kuaj mob sib xyaw, lub tuam txhab tsim ntau dua 20 lab hydrophilic catheters txhua xyoo thiab xa tawm mus rau ntau dua 25 lub tebchaws, pabcuam cov neeg faib khoom, cov tswv lag luam, thiab cov neeg koom tes OEM thoob plaws Tebchaws Europe, North America, thiab thaj av Asia-Pacific.
Tsab xov xwm tshaj tawm no piav qhia txog peb theem kev cai lij choj uas DAXAN tau tsim los ua tus neeg muab khoom siv catheter OEM, lub hauv paus tsim khoom uas txhawb nqa nws, thiab qhov kev hloov kho OEM muaj rau cov neeg xa khoom thoob ntiaj teb.
DAXAN Pom Zoo Daim Ntawv Pov Thawj Triple Regulatory ua tus neeg muab khoom Catheter OEM rau cov neeg xa khoom thoob ntiaj teb
Chengdu Daxan Innovative Medical Tech Co., Ltd. tau lees paub daim ntawv pov thawj tib lub sijhawm thoob plaws peb txoj cai tswjfwm ywj pheej: CE Marking nyob rau hauv EU MDR 2017/745 (Txoj Kev Ua Haujlwm Zoo Tag Nrho), FDA 510 (k) kev tshem tawm K212567 thiab K243175, thiab Tuam Tshoj NMPA (yav tas los hu ua CFDA) kev sau npe - txhua yam tau txhawb nqa los ntawm ISO 13485: 2016 kev tswj hwm zoo. Ua ke nrog FDA Kev Sau Npe FEI 3023329815, cov ntaub ntawv ua raws cai no tso DAXAN ntawm ib pawg me me ntawm cov chaw tsim khoom urology hauv Suav teb uas tuaj yeem txhawb nqa kev tsim nyog rau cov neeg xa khoom rau EU, Tebchaws Meskas, thiab Suav teb hauv tsev los ntawm ib qho chaw.
Cov neeg xa khoom thoob ntiaj teb uas tshuaj xyuas tus neeg muag khoom catheter OEM feem ntau qhib lawv qhov kev ntsuam xyuas ntawm qib daim ntawv pov thawj: cov neeg yuav khoom EU txheeb xyuas qhov ua raws li CE MDR thiab txoj kev ceeb toom tshwj xeeb; cov neeg yuav khoom hauv Asmeskas thov 510 (k) K-tus lej thiab kev sau npe chaw; cov pab pawg yuav khoom hauv Asia-Pacific lees paub qhov xwm txheej NMPA thiab cov ntaub ntawv xa tawm.
CE MDR 2017/745 Kev Ua Raws Cai: Txoj Kev Ua Kom Zoo Tag Nrho rau Cov Neeg Ntshuam Catheter Kho Mob European
DAXAN tuav CE Marking nyob rau hauv EU MDR 2017/745 ntawm txoj kev Full Quality Assurance - txoj kev uas ua rau cov chaw tsim khoom tsim qauv thiab tsim khoom zoo rau kev saib xyuas lub cev ceeb toom, tsis yog kev kuaj xyuas hom khoom ib zaug xwb. Cov catheters sib nrug yog cais ua Class IIa cov khoom siv kho mob nyob rau hauv MDR 2017/745, thiab EU thiab EEA cov neeg xa khoom tuaj tsis tuaj yeem tso lawv rau hauv kev lag luam European yam tsis muaj CE cim raug cai raws li txoj cai hloov kho tshiab.
Rau cov neeg xa khoom hauv EU uas tau hloov kho cov saw hlau txij li thaum MDR hloov pauv, txoj kev lees paub zoo tag nrho qhia txog qib siab dua ntawm kev koom tes ntawm cov chaw tsim khoom nrog cov kev cai lij choj European. Kev tswj hwm kev tsim qauv, cov ntaub ntawv tsim khoom ntau ntau, kev tshaj tawm kev soj ntsuam tom qab kev ua lag luam, thiab pob ntawv pov thawj kev tshaj lij raug tshuaj xyuas thiab saib xyuas los ntawm Lub Koom Haum Pom Zoo - tsis tau ntsuas ib zaug thiab tso tseg.
Daim ntawv pov thawj CE MDR ntawm DAXAN npog nws cov kab khoom catheter uas muaj hydrophilic-coated intermittent. Lub kaw lus zoo ISO 13485: 2016 hauv qab no sib phim cov qauv ntaub ntawv pov thawj nrog cov qauv EU cov neeg xa khoom xav kom xa thaum lub sijhawm sau npe rau lub tebchaws.
Ob Daim Ntawv Pom Zoo FDA 510 (k) K212567 thiab K243175: Kev Nkag Mus Rau Kev Lag Luam Hauv Tebchaws Meskas rau Hydrophilic thiab TPU Intermittent Catheters
DAXAN tuav ob daim ntawv tso cai FDA 510 (k) ywj pheej: K212567, npog nws cov kab catheter hydrophilic-coated intermittent, thiab K243175, npog nws cov koob catheter TPU intermittent. Ob tus lej K tuaj yeem tshawb nrhiav rau pej xeem hauv FDA 510 (k) database, muab cov ntaub ntawv nkag mus rau hauv kev ua lag luam hauv Tebchaws Meskas uas tuaj yeem txheeb xyuas cov khoom lag luam ntawm qhov chaw ntsuas tus neeg muag khoom.
Cov qauv dual-clearance qhia txog DAXAN ob kab khoom tseem ceeb. Cov neeg faib khoom hauv Tebchaws Meskas nrhiav cov qauv hydrophilic PVC catheters siv K212567; cov neeg nrhiav cov qauv TPU variant siv K243175.
Nrog rau kev tso cai khoom lag luam, DAXAN tuav FDA Kev Sau Npe FEI 3023329815, uas tuaj yeem tshawb nrhiav tau los ntawm FDA lub chaw sau npe online. Kev tso cai khoom lag luam 510 (k) ua ke nrog kev sau npe FDA qib chaw tsim cov qauv ntaub ntawv ob txheej uas cov pab pawg tswj hwm kev cai lij choj ntawm cov neeg xa khoom hauv Tebchaws Meskas feem ntau xav tau ua ntej ua tiav kev tsim nyog ntawm tus neeg muab khoom.
Kev Sau Npe NMPA thiab Cov Ntaub Ntawv Xa Tawm: Cov Ntawv Pov Thawj Ua Raws Cai Suav Teb rau Cov Neeg Koom Tes Faib Khoom Hauv Tebchaws Es Xias
Kev sau npe NMPA hauv Suav teb (yav tas los hu ua CFDA) lees paub tias DAXAN cov khoom siv catheter tau ua tiav kev tshuaj xyuas kev cai lij choj hauv tebchaws raws li Tuam Tshoj cov txheej txheem kho mob - suav nrog kev ua raws li cov qauv khoom, kev ntsuam xyuas qhov zoo, thiab kev saib xyuas tom qab kev lag luam. Rau cov neeg xa khoom hauv Asia-Pacific uas cov txheej txheem sau npe hauv zos siv cov xwm txheej kev cai lij choj ntawm lub tebchaws tsim khoom, kev sau npe NMPA muab cov cim qhia kev ua raws cai los ntawm qhov chaw.
DAXAN kuj tseem tuav Daim Ntawv Pov Thawj Muag Khoom Dawb (FSC) thiab Daim Ntawv Pov Thawj Keeb Kwm CCPIT. FSC sau cov ntaub ntawv tsim nyog rau kev xa khoom mus rau cov lag luam sab nraum EU thiab Tebchaws Meskas cov cai tswjfwm - feem ntau xav tau los ntawm cov neeg xa khoom hauv Southeast Asia, Middle East, thiab Latin America thaum xa daim ntawv thov nkag mus rau hauv kev ua lag luam lossis daim ntawv thov rau npe khoom. Daim Ntawv Pov Thawj Keeb Kwm CCPIT ua haujlwm rau kev lis kev cai thiab cov ntaub ntawv them se hauv kev lag luam hla ciam teb, lees paub keeb kwm Suav rau kev ntsuam xyuas se thiab kev ua raws li daim ntawv cog lus faib khoom.
Ua ke, kev sau npe NMPA, FSC, thiab daim ntawv pov thawj keeb kwm CCPIT muab cov neeg koom tes faib khoom thoob plaws cov lag luam tshiab ib pob ntawv pov thawj tiav, ib qho chaw: kev ua raws li cov khoom lag luam los ntawm lub tebchaws tsim khoom, kev raug cai xa tawm, thiab kev txheeb xyuas keeb kwm.
ISO 13485: 2016 Chaw Ua Haujlwm Huv thiab 20M Lub Peev Xwm Txhua Xyoo: Lub Hauv Paus Tsim Khoom Tom Qab Daim Ntawv Pov Thawj Triple-Market
Txhua daim ntawv pov thawj kev cai lij choj hauv DAXAN cov khoom lag luam nyob ntawm tib lub hauv paus tsim khoom: chav dej huv uas muaj 6,000 m² ISO 13485: 2016 hauv Chengdu, txhawb nqa los ntawm lub chaw kuaj mob sib xyaw thiab tsim ntau dua 20 lab lub raj xa dej hydrophilic ib xyoos. Lub kaw lus tswj hwm zoo ISO 13485: 2016 tsis yog tsuas yog daim ntawv pov thawj ua ntej xwb - nws yog qhov txuas ntawm cov qauv uas txuas tag nrho peb lub moj khaum kev cai lij choj tib lub sijhawm.
Cov ntaub ntawv pov thawj CE MDR, FDA's Quality System Regulation, thiab NMPA cov qauv kev tshuaj xyuas txhua yam suav nrog ISO 13485 ua lawv lub hauv paus tseem ceeb. Vim tias ib qho QMS uas tau ntawv pov thawj yog lub hauv paus ntawm tag nrho peb daim ntawv sau npe, cov neeg xa khoom tsis tau tshuaj xyuas peb cov qauv kev ua raws cai sib luag - lawv tab tom tshuaj xyuas ib qho chaw tsim khoom uas tau sau tseg uas ua tau raws li peb tus neeg tswj hwm, qhov kev nce qib zoo hauv kev tsim nyog ntawm cov neeg xa khoom.
Lub peev xwm tsim khoom ntau tshaj 20 lab ib xyoos muab rau cov neeg xa khoom nrog kev ruaj khov ntawm kev muab khoom uas xav tau rau cov ntawv cog lus ua haujlwm, cov kev pab cuam ntau daim ntawv lo ntiag tug ntawm ntau SKU, thiab cov ntawv cog lus faib khoom uas hloov pauv tau ntau.
Cov Kev Pabcuam Catheter OEM rau Cov Neeg Ntshuam Khoom: FR Qhov Loj CH06–CH24, Kev Teeb tsa Plaub Lub Taub, thiab Kev Sau Npe Ntiag Tug
TXOJ CAIQhov kev pab cuam OEM yog tsim los rau cov neeg xa khoom tuaj uas tswj hwm ntau lub SKU urology catheter portfolios. Qhov loj ntawm Fabkis txoj kev pab them nqi suav nrog CH06 txog CH24, nrog rau qhov ntev thiab qhov taub teeb tsa txhais rau ib tus neeg ua lag luam thiab cov neeg mob. Muaj plaub hom taub hau muaj - Nelaton ncaj, Tiemann coude, pob, thiab yoog raws - ua raws li cov kev xav tau hauv kev kho mob thoob plaws lub zais zis neurogenic, BPH, urethral stricture, thiab cov cim qhia tus kheej catheterization. Kev xaiv cov khoom siv suav nrog PVC thiab DEHP-dawb, BPA-dawb TPU, nrog rau cov ntawv ntim khoom ntiag tug uas tuaj yeem hloov kho tau los ntawm hom, lus, thiab chav faib khoom.
Cov txheej hydrophilic siv thoob plaws DAXAN OEM intermittent catheter ntau yam yog lub platform Coatapex ™ Hydrolyx ™ proprietary - ib qho PVP-raws li formulation tsim los rau qhov sib txhuam qis heev thiab ruaj khov lubricity zoo tom qab ua haujlwm. Lub OEM txheej platform yog txhawb nqa los ntawm DAXAN Patent Nos. ZL201610861058.4 thiab ZL201811203221.3.
Cov tsev neeg khoom OEM muaj rau cov kev pab cuam daim ntawv lo ntiag tug suav nrog cov hydrophilic Nelaton catheter ntau yam, cov kab catheter kaw Duro-Pocket® hauv ob qho tib si RTU thiab cov hom ntawv qhib los ntawm cov hnab dej, thiab DuroFlex™ flexible-tip ISC catheter rau cov ntawv thov txog lub cev ntawm txiv neej. Txhua kab khoom yog tsim nyob rau hauv DAXAN's ISO 13485 chav huv thiab nqa cov ntawv pov thawj CE MDR, FDA 510 (k), thiab NMPA uas cuam tshuam rau nws txoj kev ua lag luam.
Rau cov neeg xa khoom uas sib sau ua ke kev ua raws li txoj cai, kev muaj peev xwm muab khoom, thiab kev ywj pheej OEM rau hauv ib qho kev sib raug zoo ntawm cov neeg muab khoom OEM catheter kho mob, Chengdu Daxan Innovative Medical Tech Co., Ltd. nthuav qhia kev xaiv tsim khoom uas tau sau tseg thiab kuaj xyuas tau. Cov lus qhia txog khoom, cov ntaub ntawv tswj hwm, thiab cov ntsiab lus ntawm OEM cov kev pab cuam muaj nyob ncaj qha los ntawm www.daxanmedical.com.