Pure Global
190309
III
Expired.Renewal application has been received.

Stents, Biliary, Metallic, Self-Expandingๆ”ฏๆžถ,่ƒ†้“,้‡‘ๅฑž,่‡ช่†จ่ƒ€

This profile provides complete Hong Kong MDACS registration information for Stents, Biliary, Metallic, Self-Expanding. 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: Stents, Biliary, Metallic, Self-Expanding

็”ขๅ“่ณ‡่จŠ๏ผš ๆ”ฏๆžถ,่ƒ†้“,้‡‘ๅฑž,่‡ช่†จ่ƒ€

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
III
Product Code
20421
Product Code Detail
20421 Stents, Biliary, Metallic, Self-Expanding
State
Expired.Renewal application has been received.
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Taewoong Medical Co., Ltd.
Taewoong Medical Co., Ltd.
South Korea
้Ÿฉๅ›ฝ
14, Gojeong-ro, Wolgot-myeon, Gimpo-si, Gyeonggi-do, Korea
้Ÿฉๅ›ฝไบฌ็•ฟ้“้‡‘ๆตฆๅธ‚ๆœˆ้ข้ซ˜ไบ•่ทฏ14ๅท
Authorised Representative (AR)
Medi-Technic Group Limited
้น„ๅฟ—ๅŒป็–—ๆœ‰้™ๅ…ฌๅธ
39132193
Regulatory Timeline
Registration Date
September 20, 2024
Expiry Date
September 23, 2024
Product Models
Niti-S Biliary Uncovered Stent [Y-type / Endoscopic Introducer] (BY1004A, BY1005A, BY1006A, BY1007A, BY1008A, BY1009A, BY1010A, BY1012A)
Niti-S ่ƒ†้“ๆœช่ฆ†็›–ๆ”ฏๆžถ [Y ๅž‹ / ๅ†…็ชฅ้•œๅผ•ๅ…ฅๅ™จ] (BY1004Aใ€BY1005Aใ€BY1006Aใ€BY1007Aใ€BY1008Aใ€BY1009Aใ€BY1010Aใ€BY1012A)