Pure Global
150250
III
current

Prostheses, Middle Ear Ossicle, Incus/Stapesๅ‡ไฝ“ใ€ไธญ่€ณๅฌๅฐ้ชจใ€็ƒฝ้ชจ/้•ซ้ชจ

This profile provides complete Hong Kong MDACS registration information for Prostheses, Middle Ear Ossicle, Incus/Stapes. 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: Prostheses, Middle Ear Ossicle, Incus/Stapes

็”ขๅ“่ณ‡่จŠ๏ผš ๅ‡ไฝ“ใ€ไธญ่€ณๅฌๅฐ้ชจใ€็ƒฝ้ชจ/้•ซ้ชจ

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
III
Product Code
16107
Product Code Detail
16107 Prostheses, Middle Ear Ossicle, Incus/Stapes
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Heinz Kurz GmbH Medizintechnik
Heinz Kurz GmbH Medizintechnik
Germany
ๅพทๅ›ฝ
Tuebinger StraรŸe 3, 72144 Dusslingen, Germany
Tuebinger StraรŸe 3, 72144 ๆœๆ–ฏๆž—ๆ น, ๅพทๅ›ฝ
Authorised Representative (AR)
Hong Kong Medical Supplies Ltd.
ๆธฏ่”ๅŒป่ฏไพ›ๅบ”ๆœ‰้™ๅ…ฌๅธ
28063112
Regulatory Timeline
Registration Date
July 19, 2019
Expiry Date
August 28, 2025
Product Models
NiTiBOND Stapes Prosthesis (1007103, 1007104, 1007105, 1007106, 1007107, 1007108, 1007109, 1007111, 1007153, 1007154, 1007155, 1007156, 1007157, 1007158, 1007159, 1007161)
NiTiBOND้•ซ้ชจๅ‡่‚ข(1007103,1007104,1007105,1007106,1007107,1007108,1007109,1007111,1007153,1007154,1007155,1007156,1007157,1007158,1007159,1007161)