241128
B
current
IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Lactate Dehydrogenase, Isoenzymeไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็ใไธดๅบๅๅญฆใ้ ถใไนณ้ ธ่ฑๆฐข้ ถใๅๅทฅ้ ถ
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Lactate Dehydrogenase, Isoenzyme. 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, Enzyme, Lactate Dehydrogenase, Isoenzyme
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็ใไธดๅบๅๅญฆใ้ ถใไนณ้ ธ่ฑๆฐข้ ถใๅๅทฅ้ ถ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
B
Product Code
18889
Product Code Detail
18889 IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Lactate Dehydrogenase, Isoenzyme
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Roche Diagnostics GmbH
Roche Diagnostics Gmbh
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
HBDH2 (05480175190, 05480175214, 06750036190, 08106053190)
HBDH2(05480175190ใ05480175214ใ06750036190ใ08106053190)