Pure Global
80168
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

MedTech Regulatory Expert

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Johnson & Johnson International
Johnson & Johnson Medtech
Belgium
ๆฏ”ๅˆฉๆ—ถ
c/o European Logistics Centre, Leonardo Da Vincilaan 15, BE-1831 Diegem, Belgium
c/o ๆฌงๆดฒ็‰ฉๆตไธญๅฟƒ,่Žฑๆ˜‚็บณๅคšยท่พพยทๆ–‡่ฅฟๅ…ฐ 15,BE-1831 ่ฟชๆตทๅง†,ๆฏ”ๅˆฉๆ—ถ
Authorised Representative (AR)
Johnson & Johnson (Hong Kong) Limited
ๅผบ็”Ÿ (้ฆ™ๆธฏ) ๆœ‰้™ๅ…ฌๅธ
27386080
Regulatory Timeline
Registration Date
August 29, 2023
Expiry Date
October 08, 2028
Product Models
MERSILENE Polyester Sterile Synthetic Non-Absorbable Surgical Suture (Suture Material (Absorbable/Non-Absorbable): Non-Absorbable; \nSuture Gauge Size: 0.1-6.0 (Metric); \nSuture Length: 10cm-2.5m; \nSuture Dyed/Undyed: Dyed/Undyed; \nSuture Color (If dyed): Green; \nCoated/Uncoated (Coating Material): Uncoated; \nMultifilament/Monofilament: Multifilament/Monofilament; \nAccessories to suture type: N/A; \nNeedled/Non-Needled: Needled/Non-Needled; \nNumber of Needles per Suture: Single Armed/Double Armed; \nNeedle material: 420 SS, 455 SS, 4310 SS and ETHALLOY; \nNeedle Coating: Silicone; \nNeedle Shape: Straight/Curve; \nNeedle Length: 3.8mm-90mm; \nNeedle Wire Diameter: 0.12mm-1.45mm)
MERSILENE่š้…ฏๆ— ่Œๅˆๆˆไธๅฏๅธๆ”ถๆ‰‹ๆœฏ็ผๅˆ็บฟ(็ผๅˆๆๆ–™(ๅฏๅธๆ”ถ/ไธๅฏๅธๆ”ถ):ไธๅฏๅธๆ”ถ; \n็ผๅˆ่ง„ๆ ผๅฐบๅฏธ:0.1-6.0(ๅ…ฌๅˆถ);\n็ผๅˆ้•ฟๅบฆ:10cm-2.5m; \n็ผๅˆๆŸ“่‰ฒ/ๆœชๆŸ“่‰ฒ:ๆŸ“่‰ฒ/ๆœชๆŸ“่‰ฒ; \n็ผๅˆ้ขœ่‰ฒ(ๅฆ‚ๆžœๆŸ“่‰ฒ):็ปฟ่‰ฒ; \nๆถ‚ๅฑ‚/ๆœชๆถ‚ๅฑ‚(ๆถ‚ๅฑ‚ๆๆ–™):ๆœชๆถ‚ๅฑ‚; \nๅคšไธ/ๅ•ไธ:ๅคไธ/ๅ•ไธ;\n็ผๅˆ็ฑปๅž‹้…ไปถ:N/A;\n้’ˆๅˆบ/้ž้’ˆๅˆบ:้’ˆๅˆบ/้ž้’ˆๅˆบ; \nๆฏๆก็ผๅˆ็บฟ็š„้’ˆๆ•ฐ:ๅ•ไธชๆญฆ่ฃ…/ๅŒๆญฆ่ฃ…;้’ˆๆ่ดจ:420 SSใ€455 SSใ€4310 SS ๅ’Œ ETHALLOY;้’ˆๆถ‚ๅฑ‚:็ก…่ƒถ;้’ˆๅฝข:็›ด็บฟ/ๆ›ฒ็บฟ;้’ˆ้•ฟ:3.8mm-90mm;้’ˆไธ็›ดๅพ„:0.12mm-1.45mm)