Pure Global
70182
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
July 05, 2022
Expiry Date
October 04, 2027
Product Models
PDS II (Polydioxanone) Sterile Synthetic, Absorbable Suture in the following range: Suture Gauge size: 0.5-5.0 (metric), Suture length: 20-240cm, Needle length: 6.5-254mm, Needle wire diameter: 0.203-1.45mm
PDS II(่šไบŒๆถ็ƒท้…ฎ)ๆ— ่Œๅˆๆˆๅฏๅธๆ”ถ็ผๅˆ็บฟ,่Œƒๅ›ดๅฆ‚ไธ‹: ็ผๅˆ็บฟ่ง„ๆ ผๅฐบๅฏธ: 0.5-5.0 (ๅ…ฌๅˆถ), ็ผๅˆ็บฟ้•ฟๅบฆ: 20-240cm, ้’ˆ้•ฟ: 6.5-254mm, ้’ˆไธ็›ดๅพ„: 0.203-1.45mm