Pure Global
100189
III
Expired.

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

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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.
Status
N/A
Pure Global
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DJ Fang

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Manufacturer (่ฃฝ้€ ๅ•†)
Medinol Ltd.
Medinol Ltd.
Israel
ไปฅ่‰ฒๅˆ—
PO Box 45026, Beck Tech Bldg. Har-Hotzvim B, Hartom Street 8, Jerusalem 9777508, Israel
้‚ฎๆ”ฟไฟก็ฎฑ 45026, ่ดๅ…‹็ง‘ๆŠ€ๅคงๅŽฆ Har-Hotzvim B, Hartom Street 8, ่€ถ่ทฏๆ’’ๅ†ท9777508, ไปฅ่‰ฒๅˆ—
Authorised Representative (AR)
Regulatory Timeline
Registration Date
June 25, 2015
Expiry Date
June 25, 2020
Product Models
X-Suit NIR Biliary Metallic Stent (SME-200P-08040, SME-200P-08060, SME-200P-08080, SME-200P-08100, SME-200P-10040, SME-200P-10060, SME-200P-10080, SME-200P-10100), X-Suit NIR Covered Biliary Metallic Stent (SME-210P-08060, SME-210P-08080, SME-210P-10060, SME-210P-10080)
X-ๅฅ—่ฃ…่ฟ‘็บขๅค–่ƒ†้“้‡‘ๅฑžๆ”ฏๆžถ(SME-200P-08040ใ€SME-200P-08060ใ€SME-200P-08080ใ€SME-200P-08100ใ€SME-200P-10040ใ€SME-200P-10060ใ€SME-200P-10080ใ€SME-200P-10100)ใ€X-ๅฅ—่ฃ…่ฟ‘็บขๅค–่ฆ†็›–่ƒ†้“้‡‘ๅฑžๆ”ฏๆžถ(SME-210P-08060ใ€SME-210P-08080ใ€SME-210P-10060ใ€SME-210P-10080)