Pure Global
140309
II
current

Procedure Kit/Trays, Biopsy, Aspiration, Bone Marrowๆ‰‹ๆœฏๅฅ—ไปถ/ๆ‰˜็›˜ใ€ๆดปๆฃ€ใ€ๆŠฝๅธใ€้ชจ้ซ“

This profile provides complete Hong Kong MDACS registration information for Procedure Kit/Trays, Biopsy, Aspiration, Bone Marrow. 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: Procedure Kit/Trays, Biopsy, Aspiration, Bone Marrow

็”ขๅ“่ณ‡่จŠ๏ผš ๆ‰‹ๆœฏๅฅ—ไปถ/ๆ‰˜็›˜ใ€ๆดปๆฃ€ใ€ๆŠฝๅธใ€้ชจ้ซ“

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
II
Product Code
16833
Product Code Detail
16833 Procedure Kit/Trays, Biopsy, Aspiration, Bone Marrow
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Ireland
็ˆฑๅฐ”ๅ…ฐ
IDA Business and Technology Park, Dublin Road, Athlone, Co. Westmeath, Ireland
็ˆฑๅฐ”ๅ…ฐ้Ÿฆๆ–ฏ็‰น็ฑณๆ–ฏๅ…ฌๅธ้˜ฟๆ–ฏ้š†้ƒฝๆŸๆž—่ทฏIDAๅ•†ไธšๅ’ŒๆŠ€ๆœฏๅ›ญ
Authorised Representative (AR)
Regulatory Timeline
Registration Date
May 22, 2024
Expiry Date
October 05, 2029
Product Models
OnControl Power Driver (9401), OnControl Bone Marrow Biopsy System Needle Set (9402-VC-006, 9407-VC-006), OnControl System Sterile Procedure Tray (9403-VC-006), OnControl Bone Marrow Biopsy System Tray (9408-VC-006, 9411-VC-006), OnControl Aspiration System Needle Set (9425-VC-006, 9468-VC-006, 9490-VC-006), OnControl Bone Marrow Biopsy System Comprehensive Tray (9451-VC-006, 9458-VC-006), OnControl Bone Lesion Biopsy System Tray (9461-VC-006, 9462-VC-006, 9463-VC-006, 9464-VC-006, 9465-VC-006, 9466-VC-006), OnControl Sterile Connector (9467-EU-006), OnControl Ported Aspiration System Tray (9471-VC-006), OnControl Aspiration System Tray (9472-VC-006)
OnControl ็”ตๆบ้ฉฑๅŠจๅ™จ (9401), OnControl ้ชจ้ซ“ๆดปๆฃ€็ณป็ปŸ้’ˆๅคดๅฅ—ไปถ (9402-VC-006, 9407-VC-006), OnControl ็ณป็ปŸๆ— ่Œๆ‰‹ๆœฏๆ‰˜็›˜ (9403-VC-006), OnControl ้ชจ้ซ“ๆดปๆฃ€็ณป็ปŸๆ‰˜็›˜ (9408-VC-006, 9411-VC-006), OnControl ๆŠฝๅธ็ณป็ปŸ้’ˆๅคดๅฅ—ไปถ (9425-VC-006, 9468-VC-006, 9490-VC-006), OnControl ้ชจ้ซ“ๆดปๆฃ€็ณป็ปŸ็ปผๅˆๆ‰˜็›˜ (9451-VC-006, 9458-VC-006), OnControl ้ชจ็—…ๅ˜ๆดปๆฃ€็ณป็ปŸๆ‰˜็›˜ (9461-VC-006, 9462-VC-006, 9463-VC-006, 9464-VC-006, 9465-VC-006, 9466-VC-006), OnControl ๆ— ่Œ่ฟžๆŽฅๅ™จ (9467-EU-006), OnControl ็ซฏๅฃๆŠฝๅธ็ณป็ปŸๆ‰˜็›˜ (9471-VC-006), OnControl ๆŠฝๅธ็ณป็ปŸๆ‰˜็›˜ (9472-VC-006)