FDA Registration
Active
🇨🇳 China
SMARTDATA SUZHOU CO., LTD
Reg #: 3008058134
·
FEI: 3008058134
·
Expires 2026
Products
11
Proprietary Names
3
Establishment Types
4
Classifications
11
Registration Details
- Registration Name
- SMARTDATA SUZHOU CO., LTD
- Registration Number
- 3008058134
- FEI Number
- 3008058134
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- F4, Building 7, 198 Jinshan Rd
- City
- Suzhou Jiangsu
- Country
- CN
Owner / Operator
- Firm Name
- Smartdata Suzhou Co., Ltd.
- Operator Number
- 10030656
- Address
- F4, Building 7, 198 Jinshan Rd
- City
- Suzhou
- State
- Jiangsu
- Postal Code
- 215011
- Country
- CN
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Endoscopic Irrigation/Suction System | OCX | Class 2 | Gastroenterology, Urology | No | 2023-08-08 |
| Adaptor, Bulbs, Miscellaneous, For Endoscope | FFY | Class 1 | Gastroenterology, Urology | No | 2019-07-11 |
| Insufflator, Automatic Carbon-Dioxide For Endoscope | FCX | Class 2 | Gastroenterology, Urology | No | 2020-04-14 |
| Endoscope Channel Accessory | ODC | Class 2 | Gastroenterology, Urology | No | 2018-07-12 |
| Bottle, Collection And Trap, Breathing System (Uncalibrated) | CBC | Class 2 | General Hospital | No | 2026-01-21 |
| Pad, Eye | HMP | Class 1 | General, Plastic Surgery | No | 2026-01-21 |
| Accessories, Cleaning Brushes, For Endoscope | MNL | Class 1 | Gastroenterology, Urology | No | 2026-01-21 |
| Endoscopic Storage Cover | OCU | Class 2 | Gastroenterology, Urology | No | 2021-05-26 |
| Bronchoscope Accessory | KTI | Class 2 | Ear, Nose, Throat | No | 2023-07-10 |
| Endoscopic Bite Block | MNK | Class 1 | Gastroenterology, Urology | No | 2018-08-14 |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | NKC | Class 1 | Obstetrics/Gynecology | No | 2019-12-04 |
Proprietary Names
Andorate
andorate
Vacutore
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device
Repack or Relabel Medical Device
Manufacture Medical Device