FDA Registration
Active
🇨🇳 China
ENDOCLOT PLUS CO., LTD.
Reg #: 3013155768
·
FEI: 3013155768
·
Expires 2026
Products
5
Proprietary Names
5
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- ENDOCLOT PLUS CO., LTD.
- Registration Number
- 3013155768
- FEI Number
- 3013155768
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Unit 101, B8 Building, 218 Xinghu Street, Suzhou Industrial Park, China (Jiangsu) Pilot Free Trade Zone Suzhou Area
- City
- Suzhou Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K191254
Owner / Operator
- Firm Name
- EndoClot Plus Co., Ltd.
- Operator Number
- 10052433
- Address
- Unit 101, B8 Building, 218 Xinghu Street, Suzhou Industrial Park
- City
- Suzhou
- State
- Jiangsu
- Postal Code
- 215000
- Country
- CN
- Correspondent
- Hendry Zhang
US Agent
- Business Name
- EndoClot Plus.,Inc.
- Contact Name
- Kari Song
- Address
- 5201 GREAT AMERICA PKWY STE 526
- City
- Santa Clara
- State
- CA
- ZIP
- 95054
- Country
- US
- [email protected]
- Phone
- 408 9809125
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Submucosal Injection Agent | PLL | Class 2 | Gastroenterology, Urology | No | 2020-03-30 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2017-02-15 |
| Compressor, Air, Portable | BTI | Class 2 | Anesthesiology | No | 2021-03-02 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2022-03-14 |
| Hemostatic Device For Endoscopic Gastrointestinal Use | QAU | Class 2 | General, Plastic Surgery | No | 2021-05-26 |
Proprietary Names
EndoClot SIS
EndoClot Applicator
EndoClot Air Compressor
EndoClot Air Compressor Connecting Tube
EndoClot PHS
Establishment Types
Manufacture Medical Device