100404
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)
Johnson & Johnson International
Johnson & Johnson Medtech
Belgium
ๆฏๅฉๆถ
c/o European Logistics Centre, Leonardo Da Vincilaan 15, BE-1831 Diegem, Belgium
c/o ๆฌงๆดฒ็ฉๆตไธญๅฟ,่ฑๆ็บณๅคยท่พพยทๆ่ฅฟๅ
ฐ 15,BE-1831 ่ฟชๆตทๅง,ๆฏๅฉๆถ
Authorised Representative (AR)
Johnson & Johnson (Hong Kong) Limited
ๅผบ็ (้ฆๆธฏ) ๆ้ๅ
ฌๅธ
27386080
Regulatory Timeline
Registration Date
October 07, 2024
Expiry Date
November 11, 2025
Product Models
PDS Plus Antibacterial (polydioxanone) Suture (Suture Gauge Size: 0.7 - 4.0 (metric); Suture Length: 35 cm - 245 cm; Needle Length: 7.9 mm - 70 mm; Needle Wire Diameter: 0.20 mm - 1.55 mm; Triclosan Maximum Levels </= 2360 ug/m)
PDS Plusๆ่(่ไบๆถ็ท้
ฎ)็ผๅ็บฟ(็ผๅ้่งๅฐบๅฏธ:0.7 - 4.0(ๅ
ฌๅถ);็ผๅ็บฟ้ฟๅบฆ:35ๅ็ฑณ-245ๅ็ฑณ;้้ฟ: 7.9 ๆฏซ็ฑณ - 70 ๆฏซ็ฑณ;้็บฟ็ดๅพ: 0.20 ๆฏซ็ฑณ - 1.55 ๆฏซ็ฑณ;ไธๆฐฏ็ๆ้ซๆฐดๅนณ </= 2360 ug/m)