Pure Global
90036
IV
current

Sutures, Synthetic, Absorbable, Poliglecaprone็ผๅˆ็บฟ,ๅˆๆˆ,ๅฏๅธๆ”ถ,่š็ณ–่ƒถๅˆ็บฟ

This profile provides complete Hong Kong MDACS registration information for Sutures, Synthetic, Absorbable, Poliglecaprone. 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, Poliglecaprone

็”ขๅ“่ณ‡่จŠ๏ผš ็ผๅˆ็บฟ,ๅˆๆˆ,ๅฏๅธๆ”ถ,่š็ณ–่ƒถๅˆ็บฟ

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
20884
Product Code Detail
20884 Sutures, Synthetic, Absorbable, Poliglecaprone
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
November 27, 2023
Expiry Date
February 24, 2029
Product Models
MONOCRYL Plus Antibacterial Poliglecaprone - 25 (Monofilament) Sterile Synthetic Absorbable Surgical Suture (Suture Material: Absorbable; Suture Gauge Size: 0.7-4.0 (Metric); Suture Length: 45-90cm; Suture Dyed/Undyed: Dyed/Undyed; Suture Color (If dyed): Violet #2; Suture Coated/Uncoated: Uncoated; Multifilament/Monofilament: Monofilament; Contains Antimicrobials (Yes/No): Yes; Triclosan Maximum Levels: โ‰ค 2360 ฮผg/m; Accessories to suture type: N/A; Suture Needled/Non-Needled: Needled; Number of Needles per Suture: Single Armed/Double Armed; Needle material: 420 SS, 455 SS, 4310 SS, ETHALLOY; Needle Coating: Silicone, CERBERUS, MULTIPASS; Needle Shape: Straight/Curve; Needle Colour: Silver/Black; Needle Length: 10-60.3mm; Needle Wire Diameter: 0.25-1.3mm)
MONOCRYLๅŠ ๆŠ—่Œ่š็ณ–-25(ๅ•ไธ)ๆ— ่Œๅˆๆˆๅฏๅธๆ”ถๆ‰‹ๆœฏ็ผๅˆ็บฟ(็ผๅˆๆๆ–™:ๅฏๅธๆ”ถ;็ผๅˆ้‡่ง„ๅฐบๅฏธ:0.7-4.0(ๅ…ฌๅˆถ);็ผๅˆ็บฟ้•ฟๅบฆ:45-90ๅŽ˜็ฑณ;็ผๅˆๆŸ“่‰ฒ/ๆœชๆŸ“่‰ฒ:ๆŸ“่‰ฒ/ๆœชๆŸ“่‰ฒ;็ผๅˆ้ขœ่‰ฒ(ๅฆ‚ๆžœๆŸ“่‰ฒ):็ดซ่‰ฒ#2;็ผๅˆ็บฟๆถ‚ๅฑ‚/ๆ— ๆถ‚ๅฑ‚:ๆ— ๆถ‚ๅฑ‚;ๅคไธ/ๅ•ไธ:ๅ•ไธ;ๅซๆœ‰ๆŠ—่Œๅ‰‚(ๆ˜ฏ/ๅฆ):ๆ˜ฏ;ไธ‰ๆฐฏ็”Ÿๆœ€้ซ˜ๆฐดๅนณ:โ‰ค2360ๅพฎๅ…‹/็ฑณ;็ผๅˆ็บฟ้™„ไปถ:ไธ้€‚็”จ;็ผๅˆ้’ˆๅˆบ/้ž้’ˆๅˆบ:้’ˆๅˆบ;ๆฏๆก็ผๅˆ็บฟ้’ˆๆ•ฐ:ๅ•่‡‚/ๅŒ่‡‚;้’ˆๆๆ–™: 420 ไธ้”ˆ้’ข, 455 ไธ้”ˆ้’ข, 4310 ไธ้”ˆ้’ข, ไน™ๅˆ้‡‘;้’ˆๅคดๆถ‚ๅฑ‚:็ก…่ƒถใ€ๅœฐ็‹ฑ็Šฌใ€ๅคš้€š้“;้’ˆๅฝข:็›ด็บฟ/ๆ›ฒ็บฟ;้’ˆ้ขœ่‰ฒ:้“ถ่‰ฒ/้ป‘่‰ฒ;้’ˆ้•ฟ:10-60.3ๆฏซ็ฑณ;้’ˆ็บฟ็›ดๅพ„:0.25-1.3ๆฏซ็ฑณ)