Stents, Biliary, Metallic, Self-Expanding支架,胆道,金属,自膨胀

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

產品資訊： 支架,胆道,金属,自膨胀

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

current

Status

N/A

DJ Fang

MedTech Regulatory Expert

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Pricing

Manufacturer (製造商)

Taewoong Medical Co., Ltd.

South Korea

韩国

14 Gojeong-ro, Wolgot-myeon, Gimpo-si, Gyeonggi-do, Korea

韩国京畿道金浦市月垣面高亭路14号

Authorised Representative (AR)

Medi-Technic Group Limited

鹄志医疗有限公司

39132193

Regulatory Timeline

Registration Date

September 20, 2024

Expiry Date

February 20, 2028

Product Models

Niti-S Biliary Covered Stent (Full Covered-type/ Endoscopic Introducer) (BS0603F, BS0604F, BS0605F, BS0606F, BS0607F, BS0608F, BS0609F, BS0610F, BS0612F, BS0803F, BS0804F, BS0805F, BS0806F, BS0807F, BS0808F, BS0809F, BS0810F, BS0812F, BS1003F, BS1004F, BS1005F, BS1006F, BS1007F, BS1008F, BS1009F, BS1010F, BS1012F)

Niti-S 胆道覆膜支架(全覆盖型/内窥镜导引器)(BS0603F、BS0604F、BS0605F、BS0606F、BS0607F、BS0608F、BS0609F、BS0610F、BS0612F、BS0803F、BS0804F、BS0805F、BS0806F、BS0807F、BS0808F、BS0809F、BS0810F、BS0812F、BS1003F、BS1004F、BS1005F、BS1006F、BS1007F、BS1008F、BS1009F、BS1010F、BS1012F)