FDA Registration
Active
🇨🇳 China
Sansure Biotech Inc.
Reg #: 3016619649
·
FEI: 3016619649
·
Expires 2026
Products
4
Proprietary Names
15
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Sansure Biotech Inc.
- Registration Number
- 3016619649
- FEI Number
- 3016619649
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 680, Lusong Road, Yuelu District
- City
- Changsha Hunan
- Country
- CN
Owner / Operator
- Firm Name
- Sansure Biotech Inc.
- Operator Number
- 10077049
- Address
- No. 680, Lusong Road, Yuelu District
- City
- Changsha
- State
- Hunan
- Postal Code
- 410205
- Country
- CN
US Agent
- Business Name
- Emergo Global Representation LLC
- Contact Name
- Yong Sun
- Address
- 2500 Bee Cave Rd., Bldg. 1, Ste. 300
- City
- Austin
- State
- TX
- ZIP
- 78746
- Country
- US
- [email protected]
- Phone
- 512 3279997
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Real Time Nucleic Acid Amplification System | OOI | Class 2 | Clinical Chemistry | No | 2021-12-29 |
| Reagents, 2019-Novel Coronavirus Nucleic Acid | QJR | Class N | Unknown | No | 2020-08-10 |
| Clinical Sample Concentrator | JJH | Class 1 | Clinical Chemistry | No | 2020-11-05 |
| Culture Media, Non-Selective And Non-Differential | JSG | Class 1 | Microbiology | No | 2025-09-05 |
Proprietary Names
Q-Vera Prima 96 qPCR Instrument
Q-Vera Pico 6X qPCR Instrument
Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
Nucleic Acid Extraction-Purification Kit 2
NATCH S-F11C System
Nucleic Acid Extraction-Purification Kit 3
Nucleic Acid Extraction-Purification Kit 4
Multi-type Sample DNA/RNA Extraction-Purification Kit (Magnetic beads method)
X-Lysa Flex System
X-Lysa Solo System
NATCH S-F11B System
Nucleic Acid Extraction and Purification Kit 3
Nucleic Acid Extraction and Purification Kit 2
Nucleic Acid Extraction and Purification Kit 1
Sample Storage Reagent
Establishment Types
Manufacture Medical Device