241098
B
current
IVD Test Reagent/Kits, Immunoassay, Protein, Alpha-1-Antitrypsinไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็, ๅ ็ซๆฃๆต, ่็ฝ่ดจ, ฮฑ-1-ๆ่ฐ่็ฝ้ ถ
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Protein, Alpha-1-Antitrypsin. 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, Immunoassay, Protein, Alpha-1-Antitrypsin
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็, ๅ ็ซๆฃๆต, ่็ฝ่ดจ, ฮฑ-1-ๆ่ฐ่็ฝ้ ถ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
B
Product Code
17257
Product Code Detail
17257 IVD Test Reagent/Kits, Immunoassay, Protein, Alpha-1-Antitrypsin
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Roche Diagnostics GmbH
Roche Diagnostics Gmbh
Germany
ๅพทๅฝ
Sandhofer Strasse 116, 68305 Mannheim, Germany
Sandhofer Strasse 116, 68305 ๆผๆตทๅง, ๅพทๅฝ
Authorised Representative (AR)
Regulatory Timeline
Registration Date
October 16, 2024
Expiry Date
October 15, 2029
Product Models
AAT2 (08101396190, 05991978190, 03005771322)
AAT2(08101396190ใ05991978190ใ03005771322)