Pure Global
150334
D
Expired.

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

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

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

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
D
Product Code
19296
Product Code Detail
19296 IVD Test Reagent/Kits, Immunohematology, Blood Grouping, Rhesus Typing
State
Expired.
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
DiaMed Holding GmbH
DiaMed Holding GmbH
Switzerland
็‘žๅฃซ
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
November 11, 2015
Expiry Date
November 11, 2020
Product Models
Bio-Rad Rh-Subgroups + K (50100), DiaClon Rh-Subgroups + K (50110), Rh-Subgroups + Cw + K (50120), RhD + Phenotype (50130), ID-DiaClon Anti-c (50850), DiaClon Anti-C (10600), DiaClon Anti-c (10610), DiaClon Anti-E (10620), DiaClon Anti-e (10630)
Bio-Rad Rh ไบš็ป„ + K (50100), DiaClon Rh ไบš็ป„ + K (50110), Rh ไบš็ป„ + Cw + K (50120), RhD + ่กจๅž‹ (50130), ID-DiaClon ๆŠ— C (50850), DiaClon ๆŠ— C (10600), DiaClon ๆŠ— C (10610), DiaClon Anti-E (10620), DiaClon Anti-E (10630)