Pure Global
240418
C
current

IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Anticonvulsant, Valproic Acidไฝ“ๅค–่ฏŠๆ–ญๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’, ๅ…็–ซๆต‹ๅฎš, ๆฒป็–—่ฏ็‰ฉ, ๆŠ—ๆƒŠๅŽฅ่ฏ, ไธ™ๆˆŠ้…ธ

This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Anticonvulsant, Valproic Acid. 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, Anticonvulsant, Valproic Acid

็”ขๅ“่ณ‡่จŠ๏ผš ไฝ“ๅค–่ฏŠๆ–ญๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’, ๅ…็–ซๆต‹ๅฎš, ๆฒป็–—่ฏ็‰ฉ, ๆŠ—ๆƒŠๅŽฅ่ฏ, ไธ™ๆˆŠ้…ธ

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
C
Product Code
20036
Product Code Detail
20036 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Anticonvulsant, Valproic Acid
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Roche Diagnostics GmbH
Roche Diagnostics Gmbh
Germany
ๅพทๅ›ฝ
Sandhofer Strasse 116, 68305 Mannheim, Germany
Sandhofer Strasse 116, 68305 ๆ›ผๆตทๅง†, ๅพทๅ›ฝ
Authorised Representative (AR)
Regulatory Timeline
Registration Date
September 24, 2024
Expiry Date
September 23, 2029
Product Models
VALP2 (04491041190, 05108438190, 05888549190, 08058814190, 08445575190)
VALP2 (04491041190ใ€ 05108438190ใ€ 05888549190ใ€ 08058814190ใ€ 08445575190)