Pure Global
240088
D
current

IVD Test Reagent/Kits, Immunohematology, Blood Grouping, ABO Typingไฝ“ๅค–่ฏŠๆ–ญ ๆต‹่ฏ•่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€ๅ…็–ซ่ก€ๆถฒๅญฆใ€่ก€ๅž‹ใ€ABO ๅˆ†ๅž‹

This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunohematology, Blood Grouping, ABO Typing. 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, Immunohematology, Blood Grouping, ABO Typing

็”ขๅ“่ณ‡่จŠ๏ผš ไฝ“ๅค–่ฏŠๆ–ญ ๆต‹่ฏ•่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€ๅ…็–ซ่ก€ๆถฒๅญฆใ€่ก€ๅž‹ใ€ABO ๅˆ†ๅž‹

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
D
Product Code
19295
Product Code Detail
19295 IVD Test Reagent/Kits, Immunohematology, Blood Grouping, ABO Typing
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
DiaMed GmbH
Diamed Gmbh
Pra Rond 23, 1785 Cressier FR, SWITZERLAND
Pra Rond 23, 1785 ๅ…‹้›ท่ฅฟ่€ถ่”้‚ฆๅ…ฌๆŠฅ, ็‘žๅฃซ
Authorised Representative (AR)
2789 3300 / 63365950
Regulatory Timeline
Registration Date
March 21, 2024
Expiry Date
March 20, 2029
Product Models
DiaClon Complete Crossmatch (50601) (004615)
DiaClon ๅฎŒๅ…จไบคๅ‰้…ๅž‹ (50601) (004615)