FDA Registration
Active
🇨🇳 China
ZONEFLY MEDICAL DEVICES CO., LTD.
Reg #: 3009460127
·
FEI: 3009460127
·
Expires 2026
Products
7
Proprietary Names
2
Establishment Types
4
Classifications
7
Registration Details
- Registration Name
- ZONEFLY MEDICAL DEVICES CO., LTD.
- Registration Number
- 3009460127
- FEI Number
- 3009460127
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- LIANHU LAO ZHAODAISUO, LIANHU ROAD
- City
- Danyang Jiangsu
- Country
- CN
Owner / Operator
- Firm Name
- ZONEFLY MEDICAL DEVICES CO., LTD.
- Operator Number
- 10040910
- Address
- LIANHU LAO ZHAODAISUO, LIANHU ROAD
- City
- Danyang
- State
- Jiangsu
- Postal Code
- 212300
- Country
- CN
- Correspondent
- Chaohui Jiang
US Agent
- Business Name
- RAC CORPORATION
- Contact Name
- Macrae Carden
- Address
- 1023 Presidio Dr
- City
- Costa Mesa
- State
- CA
- ZIP
- 92626
- Country
- US
- [email protected]
- Phone
- 949 4126689
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2012-07-30 |
| Wheel, Polishing Agent | EJQ | Class 1 | Dental | No | 2018-01-17 |
| Bur, Ear, Nose And Throat | EQJ | Class 1 | Ear, Nose, Throat | No | 2015-01-12 |
| Respirator, Surgical | MSH | Class 2 | General, Plastic Surgery | No | 2020-03-24 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2012-06-01 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2015-01-12 |
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 2015-01-12 |
Proprietary Names
WHEEL, POLISHING AGENT
Respirator, surgical
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility