241053
B
current
IVD Test Reagent/Kits, Immunoassay, Vitamin, Folateไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ ็ซๆตๅฎใ็ปด็็ด ใๅถ้ ธ
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Vitamin, Folate. 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, Vitamin, Folate
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ ็ซๆตๅฎใ็ปด็็ด ใๅถ้ ธ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
B
Product Code
19144
Product Code Detail
19144 IVD Test Reagent/Kits, Immunoassay, Vitamin, Folate
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
September 24, 2024
Expiry Date
September 23, 2029
Product Models
CalSet Folate (08324247190), Folate III CalSet (08324182190), Elecsys Folate III (08324174190), Elecsys Folate III (08324131190)
CalSet ๅถ้
ธ (08324247190)ใๅถ้
ธ III CalSet (08324182190)ใElecsys ๅถ้
ธ III (08324174190)ใElecsys ๅถ้
ธ III (08324131190)