241052
C
current
IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Immunosuppressant, Tacrolimusไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็, ๅ ็ซๆตๅฎ, ๆฒป็่ฏ็ฉ, ๅ ็ซๆๅถๅ, ไปๅ ่ซๅธ
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Immunosuppressant, Tacrolimus. 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, Therapeutic Drug, Immunosuppressant, Tacrolimus
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็, ๅ ็ซๆตๅฎ, ๆฒป็่ฏ็ฉ, ๅ ็ซๆๅถๅ, ไปๅ ่ซๅธ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
C
Product Code
20045
Product Code Detail
20045 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Immunosuppressant, Tacrolimus
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
Tacrolimus CalSet (05889065190), Elecsys Tacrolimus (07251254190), Elecsys Tacrolimus (05889057190)
ไปๅ
่ซๅธ CalSet (05889065190)ใElecsys ไปๅ
่ซๅธ (07251254190)ใElecsys ไปๅ
่ซๅธ (05889057190)