FDA Registration
Active
🇨🇳 China
Breath Alcohol Test
Reg #: 3009585529
·
FEI: 3009585529
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- ASSURE TECH. (HANGZHOU) CO., LTD.
- Registration Number
- 3009585529
- FEI Number
- 3009585529
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Building 4, No. 1418-50, Moganshan Road, Gongshu District
- City
- Hangzhou Zhejiang
- Country
- CN
Owner / Operator
- Firm Name
- Assure Tech. (Hangzhou) Co., Ltd.
- Operator Number
- 10040710
- Address
- Building 4, No. 1418-50, Moganshan Road, Gongshu District
- City
- Hangzhou
- State
- Zhejiang
- Postal Code
- 310011
- Country
- CN
- Correspondent
- Shisheng Ling
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Devices, Breath Trapping, Alcohol | DJZ | Class 1 | Clinical Toxicology | No | 2023-08-07 |
Proprietary Names
Breath Alcohol Test
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device