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Registrant profile

Guangzhou Kofa BIOTECHNOLOGY Co., Ltd.

广州科方生物技术股份有限公司
Guangdong·China NMPA·216 registered devices
216
Total devices
2
Device classes
2017
Earliest approval
2024
Latest approval
Company overview
Total devices
216
Province/Region
Guangdong
广东
Address
Building C4, No. 11 Kaiyuan Avenue, Science City, Guangzhou High-tech Industrial Development Zone, has five floors and six floors
广州高新技术产业开发区科学城开源大道11号C4栋五层、六层
Registration timeline
Earliest approval
Feb 27, 2017
Latest approval
Dec 19, 2024
Device class distribution
Breakdown of 216 devices by regulatory classification
Class II
210
97.2% of total
Class III
6
2.8% of total
Registered devices (10 most recent shown)
Click on any device for detailed registration information
Product nameClassRegistration numberApproval dateExpiry dateDetail
胰岛素样生长因子结合蛋白-3(IGFBP-3)测定试剂盒(化学发光法)
胰岛素样生长因子结合蛋白-3（IGFBP-3）测定试剂盒（化学发光法）
Class II粤械注准20242401697Dec 19, 2024Dec 18, 2029View
Laminin (LN) Determination Reagent Kit (Chemiluminescence Method)
层粘连蛋白（LN）测定试剂盒（化学发光法）
Class II粤械注准20242401626Dec 06, 2024Dec 05, 2029View
Type IV collagen assay kit (chemiluminescence method)
Ⅳ型胶原测定试剂盒（化学发光法）
Class II粤械注准20242401625Dec 06, 2024Dec 05, 2029View
Anti-cyclic citrullinated peptide (CCP) antibody assay kit (chemiluminescence)
抗环瓜氨酸肽（CCP）抗体测定试剂盒（化学发光法）
Class II粤械注准20242401627Dec 06, 2024Dec 05, 2029View
骨钙素(BGP)测定试剂盒(化学发光法)
骨钙素（BGP）测定试剂盒（化学发光法）
Class II粤械注准20242401391Oct 22, 2024Oct 21, 2029View
S100蛋白(S100)测定试剂盒(化学发光法)
S100蛋白（S100）测定试剂盒(化学发光法)
Class II粤械注准20242401390Oct 22, 2024Oct 21, 2029View
降钙素(CT)测定试剂盒(化学发光法)
降钙素（CT）测定试剂盒(化学发光法)
Class II粤械注准20242401381Oct 16, 2024Oct 15, 2029View
醛固酮(ALD)测定试剂盒(化学发光法)
醛固酮（ALD）测定试剂盒（化学发光法）
Class II粤械注准20242401377Oct 16, 2024Oct 15, 2029View
生长激素(GH)测定试剂盒(化学发光法)
生长激素（GH）测定试剂盒（化学发光法）
Class II粤械注准20242401380Oct 16, 2024Oct 15, 2029View
促肾上腺皮质激素(ACTH)测定试剂盒(化学发光法)
Class II粤械注准20242401378Oct 16, 2024Oct 15, 2029View
About this profile

Complete regulatory portfolio for Guangzhou Kofa BIOTECHNOLOGY Co., Ltd. in China's medical device market. This registrant has 216 medical devices registered with China NMPA, with registrations dating from Feb 27, 2017 to Dec 19, 2024.

Browse the complete device portfolio including device classifications, registration numbers, approval dates, and technical specifications. Pure Global AI provides free access to comprehensive China NMPA registration data, helping global MedTech companies analyze market presence and regulatory compliance for Chinese medical device manufacturers.