Registrant profile
InTec Products, INC.
英科新创（厦门）科技股份有限公司
Fujian·China NMPA·146 registered devices
146
Total devices
2
Device classes
2019
Earliest approval
2024
Latest approval
Company overview
- Total devices
- 146
- Province/Region
- Fujian福建
- Address
- No. 332, Xinguang Road, Xiamen Xinyang Industrial Zone, Haicang厦门市海沧新阳工业区新光路332号
Registration timeline
- Earliest approval
- Apr 18, 2019
- Latest approval
- Aug 08, 2024
Device class distribution
Breakdown of 146 devices by regulatory classification
Class II
104
71.2% of total
Class III
42
28.8% of total
Registered devices (10 most recent shown)
Click on any device for detailed registration information
| Product name | Class | Registration number | Approval date | Expiry date | Detail |
|---|---|---|---|---|---|
Fritsamine (FMN) calibrator 果糖胺（FMN）校准品 | Class II | 闽械注准20242400141 | Aug 08, 2024 | Aug 07, 2029 | View |
Fructosamine (FMN) control 果糖胺（FMN）质控品 | Class II | 闽械注准20242400142 | Aug 08, 2024 | Aug 07, 2029 | View |
5'-Nucleotidase (5'-NT) quality control product 5′-核苷酸酶（5′-NT）质控品 | Class II | 闽械注准20242400139 | Aug 06, 2024 | Aug 05, 2029 | View |
Glycosylated hemoglobin (HbA1c) calibrator 糖化血红蛋白（HbA1c）校准品 | Class II | 闽械注准20242400136 | Aug 06, 2024 | Aug 05, 2029 | View |
5′-核苷酸酶(5′-NT)校准品 5′-核苷酸酶（5′-NT）校准品 | Class II | 闽械注准20242400138 | Aug 06, 2024 | Aug 05, 2029 | View |
Glycated hemoglobin (HbA1c) quality control material 糖化血红蛋白（HbA1c）质控品 | Class II | 闽械注准20242400137 | Aug 06, 2024 | Aug 05, 2029 | View |
Microalbumin calibrator 微量白蛋白校准品 | Class II | 闽械注准20242400134 | Aug 06, 2024 | Aug 05, 2029 | View |
Trace albumin control material 微量白蛋白质控品 | Class II | 闽械注准20242400135 | Aug 06, 2024 | Aug 05, 2029 | View |
C-reactive protein calibrator C反应蛋白校准品 | Class II | 闽械注准20242400108 | Jul 12, 2024 | Jul 11, 2029 | View |
C-reactive Protein (CRP) Quality Control Material C反应蛋白（CRP）质控品 | Class II | 闽械注准20242400099 | Jul 02, 2024 | Jul 01, 2029 | View |
About this profile
Complete regulatory portfolio for InTec Products, INC. in China's medical device market. This registrant has 146 medical devices registered with China NMPA, with registrations dating from Apr 18, 2019 to Aug 08, 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.