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 (Both Bare-type / Endoscopic Introducer) (BS0604B, BS0605B, BS0606B, BS0607B, BS0608B, BS0609B, BS0610B, BS0612B, BS0804B, BS0805B, BS0806B, BS0807B, BS0808B, BS0809B, BS0810B, BS0812B, BS1004B, BS1005B, BS1006B, BS1007B, BS1008B, BS1009B, BS1010B, BS1012B)

Niti-S 胆道覆盖支架(裸型/内窥镜引入器)(BS0604B、BS0605B、BS0606B、BS0607B、BS0608B、BS0609B、BS0610B、BS0612B、BS0804B、BS0805B、BS0806B、BS0807B、BS0808B、BS0809B、BS0810B、BS0812B、BS1004B、BS1005B、BS1006B、BS1007B、BS1008B、BS1009B、BS1010B、BS1012B)