Pure Global
170098
III
current

Scanning Systems, Computed Tomography/Positron Emission Tomographyๆ‰ซๆ็ณป็ปŸ,่ฎก็ฎ—ๆœบๆ–ญๅฑ‚ๆ‰ซๆ/ๆญฃ็”ตๅญๅ‘ๅฐ„ๆ–ญๅฑ‚ๆ‰ซๆ

This profile provides complete Hong Kong MDACS registration information for Scanning Systems, Computed Tomography/Positron Emission Tomography. 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: Scanning Systems, Computed Tomography/Positron Emission Tomography

็”ขๅ“่ณ‡่จŠ๏ผš ๆ‰ซๆ็ณป็ปŸ,่ฎก็ฎ—ๆœบๆ–ญๅฑ‚ๆ‰ซๆ/ๆญฃ็”ตๅญๅ‘ๅฐ„ๆ–ญๅฑ‚ๆ‰ซๆ

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
III
Product Code
20161
Product Code Detail
20161 Scanning Systems, Computed Tomography/Positron Emission Tomography
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Siemens Medical Solutions USA, Inc
Siemens Medical Solutions Usa , Inc.
United States
็พŽๅ›ฝ
Molecular Imaging, 2501 N. Barrington Road, Hoffman Estates, Illinois, 60192, USA
ๅˆ†ๅญๆˆๅƒ, 2501 N. ๅทดๆž—้กฟ่ทฏ, ้œๅคซๆ›ผๅบ„ๅ›ญ, ไผŠๅˆฉ่ฏบไผŠๅทž, 60192, ็พŽๅ›ฝ
Authorised Representative (AR)
Siemens Healthcare Limited
่ฅฟ้—จๅญๅŒป็–—ๆœ‰้™ๅ…ฌๅธ
25833388
Regulatory Timeline
Registration Date
June 05, 2023
Expiry Date
April 21, 2027
Product Models
Biograph Horizon (10532746, 10532748)
ไผ ่ฎฐๅœฐๅนณ็บฟ(10532746,10532748)