230338
IV
current
Sutures, Synthetic, Absorbable, Poliglecaprone็ผๅ็บฟ,ๅๆ,ๅฏๅธๆถ,่็ณ่ถๅ็บฟ
This profile provides complete Hong Kong MDACS registration information for Sutures, Synthetic, Absorbable, Poliglecaprone. 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, Poliglecaprone
็ขๅ่ณ่จ๏ผ ็ผๅ็บฟ,ๅๆ,ๅฏๅธๆถ,่็ณ่ถๅ็บฟ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
20884
Product Code Detail
20884 Sutures, Synthetic, Absorbable, Poliglecaprone
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 26, 2023
Expiry Date
September 26, 2028
Product Models
MONOFIL FAST - Sterile Poly(glycolide-co-ฮต-caprolactone) monofilament synthetic surgical suture, short term absorption (FW375Q, FV389Q, FW378Q, FV386Q, FU395Q, FV802Q, FU799Q, FS797Q, FR801Q, FU246Q, FS248Q, FV798Q, FU440Q, FS464Q, FR465Q, FU800Q, FS445Q, FR458Q, FS414Q, FR479Q, FR887Q, FS730Q, FW515Q, FV516Q, FV533Q, FU534Q, FY484Q, FX487Q, FY488Q, FX489Q, FW492Q, FX505Q, FW812Q, FV526Q, FW522Q, FV523Q, FU871Q, FU429Q, FUPQ, FVQ, FUQ, FSQ, KEP001Q)
MONOFIL FAST - ๆ ่่(ไนไบคๅ็ฉ-ๅ
ฑฮต-ๅทฑๅ
้
ฏ)ๅไธๅๆๆๆฏ็ผๅ็บฟ,็ญๆๅธๆถ(FW375Q,FV389Q,FW378Q,FV386Q,FU395Q,FV802Q,FU799Q,FS797Q,่้ฆๅ
ฌๆฅ801Q,FU246Q,FS248Q,FV798Q,FU440Q,FS464Q,่้ฆๅ
ฌๆฅ465Q,FU800Q,FS445Q,่้ฆๅ
ฌๆฅ458Q,FS414Q,่้ฆๅ
ฌๆฅ 479Q, ่้ฆๅ
ฌๆฅ 887Q, FS730Q, FW515Q, FV516Q, FV533Q, FU534Q, FY484Q, FX487Q, FY488Q, FX489Q, FW492Q, FX505Q, FW812Q, FV526Q, FW522Q, FV523Q, FU871Q, FU429Q, FUPQ, FVQ, FUQ, FSQ, KEP001Q)