210353
B
current
IVD Test Reagent/Kits, Immunoassay, Anemia Test, Ferritinไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ ็ซๆตๅฎใ่ดซ่กๆต่ฏใ้่็ฝ
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Anemia Test, Ferritin. 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, Anemia Test, Ferritin
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ ็ซๆตๅฎใ่ดซ่กๆต่ฏใ้่็ฝ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
B
Product Code
17342
Product Code Detail
17342 IVD Test Reagent/Kits, Immunoassay, Anemia Test, Ferritin
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Beckman Coulter, Inc.
Beckman Coulter, Inc.
United States
็พๅฝ
250 South Kraemer Blvd., Brea, California, 92821, USA
250ๅๅ
้ท้ปๅคง้,ๅธ้ทไบ,ๅ ๅฉ็ฆๅฐผไบๅท,92821,็พๅฝ
Authorised Representative (AR)
Beckman Coulter Hong Kong Limited
่ดๅ
ๆผๅบๅฐ็น้ฆๆธฏๆ้ๅ
ฌๅธ
28147431
Regulatory Timeline
Registration Date
March 07, 2024
Expiry Date
September 26, 2026
Product Models
Access Ferritin (33020, C22490), Access Ferritin Calibrators (33025)
ๆฃไฟฎ้่็ฝ (33020, C22490), ๆฃไฟฎ้่็ฝๆ กๅๅจ (33025)