230305
IV
current
Sutures, Synthetic, Absorbable, Polydioxanone็ผๅ็บฟ,ๅๆ,ๅฏๅธๆถ,่ไบๆถ็ท้ ฎ
This profile provides complete Hong Kong MDACS registration information for Sutures, Synthetic, Absorbable, Polydioxanone. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.
Product Info: Sutures, Synthetic, Absorbable, Polydioxanone
็ขๅ่ณ่จ๏ผ ็ผๅ็บฟ,ๅๆ,ๅฏๅธๆถ,่ไบๆถ็ท้ ฎ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
16584
Product Code Detail
16584 Sutures, Synthetic, Absorbable, Polydioxanone
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Assut Europe SPA
Assut Europe S.P.A.
Via Giuseppe Gregoraci, 12-00173 Roma
้่ฟๆฑๅกไฝฉยทๆ ผ้ทๆๆๅฅ,12-00173 ็ฝ้ฉฌ
Authorised Representative (AR)
Da Hon Enterprises Company Limited
่พพๅบทไผไธๆ้ๅ
ฌๅธ
27590638
Regulatory Timeline
Registration Date
September 14, 2023
Expiry Date
September 14, 2028
Product Models
ASSUFIL MONOFILAMENTO - Poly(p-dioxanone) monofilament synthetic surgical suture long term absorption, sterile (FY355M, FX365M, FX374M, FW375M, FV373M, FW371M, FV389M, FV389KM, FW378M, FV386M, FU395M, FV386KM, FU395KM, FV802M, FU799M, FS797M, FR801M, FV802XM, FU799XM, FV802ZM, FU799ZM, FV391M, FU401M, FV798M, FU440M, FS464M, FR465M, FS464XM, FR465XM, FS464ZM, FR465ZM, FU800M, FS445M, FR458M, FS593NBIM, FR593NBIM, FS414M, FR479M, FQ478M, FS414XM, FR479XM, FS414ZM, FR479ZM, FS659NBIM, FR666NBIM, FQ40ANBIM, FP742NBGM, FS748NBIM, FV541M, FS573M, FR574M, FS578M, FZ890KM, FY891KM, FY893KM, FX894KM, FX041NAEM, FX529NAEM, FX517M, FW515M, FW108NAEM, FV516M, FV533M, FV171NAEM, FU534M, FU171NAEM, FU539M, FU233NAEM, FS552M, FS233NAEM, FR239NAEM, FU548KM-B, FV563M, FU564M, FS565M, FR719M, FQ701M, FU99AKM, FW371MAP)
ASSUFIL ๅไธ - ่(ๅฏนไบๆถ็ท้
ฎ)ๅไธๅๆๆๆฏ็ผๅ็บฟ้ฟๆๅธๆถ,ๆ ่(FY355M, FX365M, FX374M, FW375M, FV373M, FW371M, FV389M, FV389KM, FW378M, FV386M, FU395M, FV386KM, FU395KM, FV802M, FU799M, FS797M, ่้ฆๅ
ฌๆฅ 801M, FV802XM, FU799XM, FV802ZM, FU799ZM, FV391M, FU401M, FV798M, FU440M, FS464M, ่้ฆๅ
ฌๆฅ 465M, FS464XM,่้ฆๅ
ฌๆฅ 465XM, FS464ZM, ่้ฆๅ
ฌๆฅ 465ZM, FU800M, FS445M, ่้ฆๅ
ฌๆฅ 458M, FS593NBIM, ่้ฆๅ
ฌๆฅ 593NBIM, FS414M, ่้ฆๅ
ฌๆฅ 479M, FQ478M, FS414XM,่้ฆๅ
ฌๆฅ 479XM, FS414ZM, ่้ฆๅ
ฌๆฅ 479ZM, FS659NBIM, ่้ฆๅ
ฌๆฅ 666NBIM, FQ40ANBIM, FP742NBGM, FS748NBIM, FV541M, FS573M, ่้ฆๅ
ฌๆฅ 574M, FS578M, FZ890KM, FY891KM, FY893KM, FX894KM, FX041NAEM, FX529NAEM, FX517M, FW515M, FW108NAEM, FV516M, FV533M, FV171NAEM, FU534M,FU171NAEM, FU539M, FU233NAEM, FS552M, FS233NAEM, ่้ฆๅ
ฌๆฅ 239NAEM, FU548KM-B, FV563M, FU564M, FS565M, ่้ฆๅ
ฌๆฅ 719M, FQ701M, FU99AKM, FW371MAP)