Pure Global
110166
IV
current

Sutures, Synthetic, Absorbable, Polydioxanone็ผๅˆ็บฟ,ๅˆๆˆ,ๅฏๅธๆ”ถ,่šไบŒๆถ็ƒท้…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

็”ขๅ“่ณ‡่จŠ๏ผš ็ผๅˆ็บฟ,ๅˆๆˆ,ๅฏๅธๆ”ถ,่šไบŒๆถ็ƒท้…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
Pure Global
DJ Fang

DJ Fang

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Ethicon, Inc.
Ethicon, Inc.
United States
็พŽๅ›ฝ
Route 22 West, P.O. Box 151, Somerville, New Jersey, 08876-0151, USA
Route 22 West, P.O. Box 151, ่จ้ป˜็ปดๅฐ”, ๆ–ฐๆณฝ่ฅฟๅทž, 08876-0151, ็พŽๅ›ฝ
Authorised Representative (AR)
Johnson & Johnson (Hong Kong) Limited
ๅผบ็”Ÿ (้ฆ™ๆธฏ) ๆœ‰้™ๅ…ฌๅธ
27386080
Regulatory Timeline
Registration Date
June 09, 2021
Expiry Date
July 07, 2026
Product Models
PDS Plus (polydioxanone) Antibacterial Suture (PDP258H, PDP259H, PDP310H, PDP416H, PDP421H, PDP422H, PDP423H, PDP441H, PDP442H, PDP443H, PDP494V, PDP496G, PDP497G, PDP507V, PDP511V, PDP515V, PDP516V, PDP593V, PDP594V, PDP662H, PDP663H, PDP682G, PDP683G, PDP823G, PDP824G, PDP833G, PDP844G, PDP844Q, PDP845G, PDP845Q, PDP9632W)
PDS Plus(่šไบŒๆถ็ƒท้…ฎ)ๆŠ—่Œ็ผๅˆ็บฟ(PDP258H,PDP259H,PDP310H,PDP416H,PDP421H,PDP422H,PDP423H,PDP441H,PDP442H,PDP443H,PDP494V,PDP496G,PDP497G,PDP507V,PDP511V,PDP515V,PDP516V,PDP593V,PDP594V,PDP662H,PDP663H,PDP682G,PDP683G,PDP823G,PDP824G,PDP833G,PDP844G,PDP844Q,PDP845G,PDP845Q,PDP9632W)