Pure Global
140037
III
current

Catheters, Urinary, Urethral, Drainage, Self-Retainedๅฏผ็ฎก,ๅฐไพฟๆฑ ,ๅฐฟ้“,ๅผ•ๆต,่‡ช็•™

This profile provides complete Hong Kong MDACS registration information for Catheters, Urinary, Urethral, Drainage, Self-Retained. 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: Catheters, Urinary, Urethral, Drainage, Self-Retained

็”ขๅ“่ณ‡่จŠ๏ผš ๅฏผ็ฎก,ๅฐไพฟๆฑ ,ๅฐฟ้“,ๅผ•ๆต,่‡ช็•™

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
III
Product Code
10720
Product Code Detail
10720 Catheters, Urinary, Urethral, Drainage, Self-Retained
State
current
Status
N/A
Pure Global
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DJ Fang

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Manufacturer (่ฃฝ้€ ๅ•†)
Sewoon Medical Co., Ltd.
Sewoon Medical Co.,Ltd
South Korea
้Ÿฉๅ›ฝ
60 Dorim-gil, Ipjang-myeon, Seobuk-gu, Cheonan-si, Chungcheongnam-do, Korea
้Ÿฉๅ›ฝๅฟ ๆธ…ๅ—้“ๅคฉๅฎ‰ๅธ‚่ฅฟๆญฆๅŒบ็›Š่—้ขๅคšๆž—่ก—60ๅท
Authorised Representative (AR)
Just Med Limited
็œŸๅ–„็พŽๅŒปๆŠคๆœ‰้™ๅ…ฌๅธ
27424370
Regulatory Timeline
Registration Date
November 27, 2023
Expiry Date
February 26, 2029
Product Models
2-way Silicone Foley Balloon Catheter (2101-006, 2101-008, 2101-010, 2101-012, 2101-014, 2101-016, 2101-018, 2101-020, 2101-022, 2101-024, 2101-026)
2 ่ทฏ็ก…่ƒถ Foley ็ƒๅ›Šๅฏผ็ฎก (2101-006, 2101-008, 2101-010, 2101-012, 2101-014, 2101-016, 2101-018, 2101-020, 2101-022, 2101-024, 2101-026)