Pure Global
240125
B
current

IVD Test Reagent/Kits, Immunoassay, Vitamin, B12 (Cyanocobalamin)ไฝ“ๅค–่ฏŠๆ–ญๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’,ๅ…็–ซๆต‹ๅฎš,็ปด็”Ÿ็ด ,B12(ๆฐฐ้’ด่ƒบ็ด )

This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Vitamin, B12 (Cyanocobalamin). 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, Vitamin, B12 (Cyanocobalamin)

็”ขๅ“่ณ‡่จŠ๏ผš ไฝ“ๅค–่ฏŠๆ–ญๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’,ๅ…็–ซๆต‹ๅฎš,็ปด็”Ÿ็ด ,B12(ๆฐฐ้’ด่ƒบ็ด )

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
B
Product Code
19141
Product Code Detail
19141 IVD Test Reagent/Kits, Immunoassay, Vitamin, B12 (Cyanocobalamin)
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Siemens Healthcare Diagnostics Inc.
Siemens Healthcare Diagnostics Inc
United States
็พŽๅ›ฝ
511 Benedict Ave, Tarrytown NY 10591, USA
511ๆœฌๅฐผ่ฟชๅ…‹็‰นๅคง้“,็บฝ็บฆๅก”้‡Œๆ•ฆ10591,็พŽๅ›ฝ
Authorised Representative (AR)
Siemens Healthcare Limited
่ฅฟ้—จๅญๅŒป็–—ๆœ‰้™ๅ…ฌๅธ
25833388
Regulatory Timeline
Registration Date
April 18, 2024
Expiry Date
April 17, 2029
Product Models
Atellica IM Active-B12 (AB12) (10733001), Atellica IM Active-B12 (AB12) Quality Control (10733002), Atellica IM Active-B12 (AB12) Master Curve Material (10733003)
Atellica IM Active-B12 (AB12) (10733001), Atellica IM Active-B12 (AB12) ่ดจ้‡ๆŽงๅˆถ (10733002), Atellica IM Active-B12 (AB12) ไธปๆ›ฒ็บฟๆๆ–™ (10733003)