Pure Global
210259
II
current

Guide Wiresๅฏผไธ

This profile provides complete Hong Kong MDACS registration information for Guide Wires. 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: Guide Wires

็”ขๅ“่ณ‡่จŠ๏ผš ๅฏผไธ

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
II
Product Code
11925
Product Code Detail
11925 Guide Wires
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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Manufacturer (่ฃฝ้€ ๅ•†)
Tokai Medical Products, Inc.
Tokai Medical Products, Inc.
Japan
ๆ—ฅๆœฌ
1485 Sarayashiki, Taraga-cho, Kasugai-City, Aichi, 486-0808 Japan
1485 Sarayashiki, Taraga-cho, ๆ˜ฅๆ—ฅไบ•ๅธ‚, ็ˆฑ็ŸฅๅŽฟ, 486-0808 ๆ—ฅๆœฌ
Authorised Representative (AR)
Regulatory Timeline
Registration Date
August 17, 2021
Expiry Date
August 17, 2026
Product Models
M-Lead Guidewire (ML16-165S-E, ML16-180S-E)
M ๅผ•็บฟๅฏผไธ (ML16-165S-E, ML16-180S-E)