Pure Global
100422
IV
current

Sutures, Synthetic, Nonabsorbable, Polyester็ผๅˆ็บฟ, ๅˆๆˆ, ้žๅธๆ”ถ, ่š้…ฏ

This profile provides complete Hong Kong MDACS registration information for Sutures, Synthetic, Nonabsorbable, Polyester. 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, Nonabsorbable, Polyester

็”ขๅ“่ณ‡่จŠ๏ผš ็ผๅˆ็บฟ, ๅˆๆˆ, ้žๅธๆ”ถ, ่š้…ฏ

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
13906
Product Code Detail
13906 Sutures, Synthetic, Nonabsorbable, Polyester
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Ethicon, LLC
Ethicon, Inc.
Puerto Rico;United States
ๆณขๅคš้ปŽๅ„;็พŽๅ›ฝ
475 C Street, Los Frailes Industrial Park, Suite 401, Guaynabo, Puerto Rico, 00969, USA
475 C Street, Los Frailes Industrial Park, Suite 401, ็“œไผŠ็บณๆฒƒ, ๆณขๅคš้ปŽๅ„, 00969, USA
Authorised Representative (AR)
Johnson & Johnson (Hong Kong) Limited
ๅผบ็”Ÿ (้ฆ™ๆธฏ) ๆœ‰้™ๅ…ฌๅธ
27386080
Regulatory Timeline
Registration Date
January 09, 2024
Expiry Date
November 26, 2025
Product Models
MERSILENE Polyester Sterile Synthetic Non-Absorbable Surgical Suture (Suture Gauge Size 0.1 โ€“ 6.0 (metric), Suture Length 10cm โ€“ 150cm, Needle Length 2 mm โ€“ 90 mm, Needle Wire Diameter 0.03 mm โ€“ 1.80 mm)
MERSILENE ่š้…ฏๆ— ่Œๅˆๆˆไธๅฏๅธๆ”ถๆ‰‹ๆœฏ็ผๅˆ็บฟ(็ผๅˆ็บฟ่ง„ๆ ผๅฐบๅฏธ 0.1 โ€“ 6.0(ๅ…ฌๅˆถ),็ผๅˆ็บฟ้•ฟๅบฆ 10cm โ€“ 150cm,้’ˆ้•ฟ 2 mm โ€“ 90 mm,้’ˆ็บฟ็›ดๅพ„ 0.03 mm โ€“ 1.80 mm)