170166
III
current
Injectors, Contrast Media, Magnetic Resonance Imagingๆณจๅฐๅจใ้ ๅฝฑๅใ็ฃๅ ฑๆฏๆๅ
This profile provides complete Hong Kong MDACS registration information for Injectors, Contrast Media, Magnetic Resonance Imaging. 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: Injectors, Contrast Media, Magnetic Resonance Imaging
็ขๅ่ณ่จ๏ผ ๆณจๅฐๅจใ้ ๅฝฑๅใ็ฃๅ ฑๆฏๆๅ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
III
Product Code
18158
Product Code Detail
18158 Injectors, Contrast Media, Magnetic Resonance Imaging
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Bayer Medical Care Inc. Also doing business as Medrad, Inc.
Bayer Medical Care Inc. Also doing business as Medrad, Inc.
United States
็พๅฝ
1 Bayer Drive, Indianola, Pennsylvania, 15051-0780, USA
1 Bayer Drive, ๅฐ็ฌฌๅฎ่ฏบๆ, ๅฎพๅคๆณๅฐผไบๅท, 15051-0780, ็พๅฝ
Authorised Representative (AR)
Prism Technologies Limited
ๆฃฑ็งๆ้ๅ
ฌๅธ
27863233
Regulatory Timeline
Registration Date
May 09, 2023
Expiry Date
July 13, 2027
Product Models
MEDRAD MRXperion MR Injection System (MRXP 200), MEDRAD MRXperion MR Injection System Sterile Disposable MRI Kit (XP 65/115VS)
็พๅพทๆๅพท MR็พ็ๆฉ็ฃๅ
ฑๆฏๆณจๅฐ็ณป็ป (MRXP 200), ็พๅพท MR็พ็ๆฉ็ฃๅ
ฑๆฏๆณจๅฐ็ณป็ปๆ ่ไธๆฌกๆง็ฃๅ
ฑๆฏๆๅ่ฏๅ็ (XP 65/115VS)