241045
B
current
IVD Test Reagent/Kits, Clinical Chemistry, Rapid Test, Urineไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็, ไธดๅบๅๅญฆ, ๅฟซ้ๆฃๆต, ๅฐฟๆถฒ
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Clinical Chemistry, Rapid Test, Urine. 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, Clinical Chemistry, Rapid Test, Urine
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็, ไธดๅบๅๅญฆ, ๅฟซ้ๆฃๆต, ๅฐฟๆถฒ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
B
Product Code
17480
Product Code Detail
17480 IVD Test Reagent/Kits, Clinical Chemistry, Rapid Test, Urine
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Roche Diagnostics GmbH
Roche Diagnostics Gmbh
Germany
ๅพทๅฝ
Sandhofer Strasse 116, 68305 Manheim, Germany
Sandhofer Strasse 116, 68305 ๆผๆตทๅง, ๅพทๅฝ
Authorised Representative (AR)
Regulatory Timeline
Registration Date
September 24, 2024
Expiry Date
September 23, 2029
Product Models
cobas u pack (06334601001)
COBAS Pack (06334601001)