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 (Flare-type / Endoscopic Introducer) (BS0604FW, BS0605FW, BS0606FW, BS0607FW, BS0608FW, BS0609FW, BS0610FW, BS0612FW, BS0804FW, BS0805FW, BS0806FW, BS0807FW, BS0808FW, BS0809FW, BS0810FW, BS0812FW, BS1004FW, BS1005FW, BS1006FW, BS1007FW, BS1008FW, BS1009FW, BS1010FW, BS1012FW)

Niti-S 胆道覆盖支架(耀斑型/内窥镜引入器)(BS0604FW、BS0605FW、BS0606FW、BS0607FW、BS0608FW、BS0609FW、BS0610FW、BS0612FW、BS0804FW、BS0805FW、BS0806FW、BS0807FW、BS0808FW、BS0809FW、BS0810FW、BS0812FW、BS1004FW、BS1005FW、BS1006FW、BS1007FW、BS1008FW、BS1009FW、BS1010FW、BS1012FW)