Pure Global
140361
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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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Biosphere Medical SA
Biosphere Medical Sa
France
ๆณ•ๅ›ฝ
Parc des Nations, Paris Nord 2, 383, rue de la Belle Etoile, Roissy-en-France, 95700, France
ไธ‡ๅ›ฝๅ…ฌๅ›ญ, ๅทด้ปŽๅŒ— 2, 383, rue de la Belle Etoile, ้ฒ็“ฆ่ฅฟๆ˜‚ๆณ•ๅ…ฐ่ฅฟ, 95700, ๆณ•ๅ›ฝ
Authorised Representative (AR)
Regulatory Timeline
Registration Date
June 24, 2024
Expiry Date
October 16, 2029
Product Models
Tenor steerable guidewire (TNR2411, TNR2412, TNR2811, TNR2812)
็”ท้ซ˜้Ÿณๅฏๆ“็บตๅฏผไธ(TNR2411ใ€TNR2412ใ€TNR2811ใ€TNR2812)