Pure Global
200505
II
Delisted

Catheter Introducers, Vascular, Central Venous, Hemostasis Valveๅฏผ็ฎกๅผ•ๅฏผๅ™จ๏ผŒ่ก€็ฎก๏ผŒไธญๅฟƒ้™่„‰๏ผŒๆญข่ก€้˜€

This profile provides complete Hong Kong MDACS registration information for Catheter Introducers, Vascular, Central Venous, Hemostasis Valve. 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: Catheter Introducers, Vascular, Central Venous, Hemostasis Valve

็”ขๅ“่ณ‡่จŠ๏ผš ๅฏผ็ฎกๅผ•ๅฏผๅ™จ๏ผŒ่ก€็ฎก๏ผŒไธญๅฟƒ้™่„‰๏ผŒๆญข่ก€้˜€

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
II
Product Code
17578
State
N/A
Status
Delisted
ๅทฒ้€€ๅธ‚
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Vascular Solutions LLC
Vascular Solutions Llc
United States
็พŽๅ›ฝ
6464 Sycamore Court North, Minneapolis, Minnesota 55369, USA
็พŽๅ›ฝๆ˜Žๅฐผ่‹่พพๅทžๆ˜Žๅฐผ้˜ฟๆณขๅˆฉๆ–ฏๅธ‚๏ผŒ6464 Sycamore Court North๏ผŒ้‚ฎๆ”ฟ็ผ–็ 55369
Authorised Representative (AR)
Innotronik Hong Kong Ltd.
ๆฐธๅˆ›ๅŠ›้ฆ™ๆธฏๆœ‰้™ๅ…ฌๅธ
28776787
Regulatory Timeline
Registration Date
December 08, 2020
Expiry Date
December 08, 2025
Delist Date
March 02, 2021
Remarks
Delisted.
ๅทฒๅพžๅˆ—่กจไธญๅˆช้™คใ€‚
Product Models
Guardian II Hemostasis Valve\t (FH101, FH101-T, FH101-25, FH101-50), Guardian II NC Hemostasis Valve (FH102, FH102-T, FH102-25, FH102-50)