Legacy registrant archive

Shanghai Kehua Bio-Engineering Co., Ltd.

上海科华生物工程股份有限公司

ShanghaiChina NMPA227 archived records

Static archiveNMPA · legacy registration snapshot

227

Archived records

2

Device classes

2017

Earliest approval

2024

Latest approval

Company overview

Archived records: 227
Province/Region: Shanghai
Address: 1189 Qinzhou North Road, Xuhui District, Shanghai

Registration timeline

Earliest approval: Jul 14, 2017
Latest approval: Dec 30, 2024

Regulatory footprint

Search Shanghai Kehua Bio-Engineering Co., Ltd. across other regulatory registries

Device class distribution

Breakdown of 227 devices by regulatory classification

Class II17074.9% of total

Class III5725.1% of total

Archived records (10 most recent shown)

Click on any device for detailed registration information

Helicobacter pylori antibody detection test kit (latex immunoturbidimetric method)

幽门螺杆菌抗体检测试剂盒（胶乳免疫比浊法）

Registration number: 国械注准20243402655
Class: Class III
Expiry date: Dec 29, 2029

肌酸激酶同工酶测定试剂盒(胶乳免疫比浊法)

肌酸激酶同工酶测定试剂盒(胶乳免疫比浊法）

Registration number: 沪械注准20242400393
Class: Class II
Expiry date: Nov 13, 2029

Abnormal prothrombin assay kit (chemiluminescence)

异常凝血酶原测定试剂盒（化学发光法）

Registration number: 国械注准20243401590
Class: Class III
Expiry date: Aug 22, 2029

Human Immunodeficiency Virus Type 1 (HIV-1) Nucleic Acid Detection Reagent Kit (PCR-Fluorescent Probe Method)

人类免疫缺陷病毒1型（HIV-1）核酸测定试剂盒（PCR-荧光探针法）

Registration number: 国械注准20243401285
Class: Class III
Expiry date: Jul 16, 2029

Trans-triiodothyronine assay kit (chemiluminescence method)

反三碘甲状腺原氨酸测定试剂盒（化学发光法）

Registration number: 沪械注准20242400208
Class: Class II
Expiry date: Jun 25, 2029

Specific growth factor determination reagent kit (chemical method)

特异性生长因子测定试剂盒（化学法）

Registration number: 沪械注准20242400177
Class: Class II
Expiry date: Jun 04, 2029

Hepatitis B virus core IgM antibody test kit (chemiluminescence method)

乙型肝炎病毒核心IgM抗体检测试剂盒（化学发光法）

Registration number: 国械注准20243400687
Class: Class III
Expiry date: Apr 10, 2029

Hepatitis E virus IgM antibody test kit (chemiluminescence method)

戊型肝炎病毒IgM抗体检测试剂盒（化学发光法）

Registration number: 国械注准20243400608
Class: Class III
Expiry date: Mar 27, 2029

亮氨酸氨基肽酶测定试剂盒(L-亮氨酰对硝基苯胺底物法)

Registration number: 沪械注准20242400042
Class: Class II
Expiry date: Feb 03, 2029

Free light chain κ assay kit (immunoturbidimetry method)

轻链κ测定试剂盒（免疫比浊法）

Registration number: 沪械注准20232400360
Class: Class II
Expiry date: Dec 25, 2028

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About this profile

This static archive contains 227 records under the historical name Shanghai Kehua Bio-Engineering Co., Ltd.. It does not establish the company's complete current portfolio or current authorization status.

Historical English translations and official Chinese names can differ. These archived names are not automatically equated with a holder in the current domestic-registration listing.