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 Bilary Covered Stent (Bumpy / Endoscopic Introducer) (BK0604CW, BK0605CW, BK0606CW, BK0607CW, BK0608CW, BK0609CW, BK0610CW, BK0612CW, BK0804CW, BK0805CW, BK0806CW, BK0807CW, BK0808CW, BK0809CW, BK0810CW, BK0812CW, BK1004CW, BK1005CW, BK1006CW, BK1007CW, BK1008CW, BK1009CW, BK1010CW, BK1012CW)

Niti-S 双侧支架(凹凸/内窥镜介绍器)(BK0604CW、BK0605CW、BK0606CW、BK0607CW、BK0608CW、BK0609CW、BK0610CW、BK0612CW、BK0804CW、BK0805CW、BK0806CW、BK0807CW、BK0808CW、BK0809CW、BK0810CW、BK0812CW、BK1004CW、BK1005CW、BK1006CW、BK1007CW、BK1008CW、BK1009CW、BK1010CW、BK1012CW)