FDA Registration
Active
🇨🇳 China
4K UHD Camera System
Reg #: 3020746799
·
FEI: 3020746799
·
Expires 2025
Products
7
Proprietary Names
1
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- SCIVITA MEDICAL TECHNOLOGY CO., LTD.
- Registration Number
- 3020746799
- FEI Number
- 3020746799
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No.2, Qingqiu Street, Suzhou Industrial Park, 215000 Suzhou, Jiangsu Prov., P.R.CHINA
- City
- suzhou Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K200216
Owner / Operator
- Firm Name
- SCIVITA MEDICAL TECHNOLOGY CO., LTD.
- Operator Number
- 10082577
- Address
- No. 2, Qingqiu Street, Suzhou Industrial Park,215000 Suzhou, Jiangsu Prov., P.R.CHINA
- City
- suzhou
- State
- Jiangsu
- Postal Code
- 215000
- Country
- CN
- Correspondent
- Wu Ruqin
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2021-08-17 |
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | FET | Class 2 | Gastroenterology, Urology | No | 2021-08-17 |
| Endoscope, Accessories, Narrow Band Spectrum | NWB | Class 2 | Gastroenterology, Urology | No | 2021-08-17 |
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 2021-08-17 |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | Class 2 | Gastroenterology, Urology | No | 2021-08-17 |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | Class 2 | Ear, Nose, Throat | No | 2021-08-17 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2021-08-17 |
Proprietary Names
4K UHD Camera System
Establishment Types
Manufacture Medical Device