Pure Global
100230
D
Delisted

IVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV-1/2ไฝ“ๅค–่ฏŠๆ–ญ่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’๏ผŒ่ก€ๆธ…ๅญฆ๏ผŒ็—…ๆฏ’๏ผŒ้€†่ฝฌๅฝ•็—…ๆฏ’๏ผŒHIV-1/2

This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV-1/2. 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: IVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV-1/2

็”ขๅ“่ณ‡่จŠ๏ผš ไฝ“ๅค–่ฏŠๆ–ญ่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’๏ผŒ่ก€ๆธ…ๅญฆ๏ผŒ็—…ๆฏ’๏ผŒ้€†่ฝฌๅฝ•็—…ๆฏ’๏ผŒHIV-1/2

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
D
Product Code
19430
State
N/A
Status
Delisted
ๅทฒ้€€ๅธ‚
Pure Global
DJ Fang

DJ Fang

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Germany
ๅพทๅ›ฝ
Emil-von-Behring-Str. 76, 35041 Marburg, Deutschland, Germany.
ๅพทๅ›ฝ้ฉฌๅฐ”ๅ ก๏ผŒEmil-von-Behring-Str. 76๏ผŒ้‚ฎๆ”ฟ็ผ–็ 35041ใ€‚
Authorised Representative (AR)
Siemens Limited
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25833388
Regulatory Timeline
Registration Date
July 08, 2010
Expiry Date
July 08, 2015
Delist Date
April 23, 2015
Remarks
Delisted.
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Product Models
Enzygnost HIV Integral II (OPAA09, OPAA13)