FDA Registration
Active
🇨🇳 China
SHANGHAI FLY MEDICAL DEVICES CO., LTD.
Reg #: 3011669217
·
FEI: 3011669217
·
Expires 2026
Products
15
Proprietary Names
16
Establishment Types
1
Classifications
15
Registration Details
- Registration Name
- SHANGHAI FLY MEDICAL DEVICES CO., LTD.
- Registration Number
- 3011669217
- FEI Number
- 3011669217
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4th Floor, Building No. 3, Block No.1, No. 3279 Sanlu Road
- City
- Minhang District Shanghai
- Country
- CN
Owner / Operator
- Firm Name
- Shanghai FLY Medical Devices Co., Ltd.
- Operator Number
- 10062948
- Address
- 4th Floor, Building No. 3, Block No.1, No. 3279 Sanlu Road
- City
- Minhang District
- State
- Shanghai
- Postal Code
- 201112
- Country
- CN
- Correspondent
- Gang Wang
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bulb, Inflation, For Endoscope | FCY | Class 1 | Gastroenterology, Urology | No | 2020-03-14 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2020-03-14 |
| Light, Examination, Medical, Battery Powered | KYT | Class 1 | General Hospital | No | 2020-03-14 |
| Depressor, Tongue, Non-Surgical | FMA | Class 1 | General Hospital | No | 2020-03-14 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2020-03-14 |
| Speculum, Rectal | FFQ | Class 1 | Gastroenterology, Urology | No | 2020-03-14 |
| Pump, Nebulizer, Manual | EPN | Class 1 | Ear, Nose, Throat | No | 2021-10-29 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2020-03-14 |
| Collector, Urine, (And Accessories) For Indwelling Catheter | KNX | Class 2 | Gastroenterology, Urology | No | 2026-05-08 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-03-14 |
| Camera, Television, Surgical, With Audio | FWC | Class 1 | General, Plastic Surgery | No | 2020-03-14 |
| Speculum, Vaginal, Nonmetal | HIB | Class 2 | Obstetrics/Gynecology | No | 2020-03-14 |
| Thermometer Kit | PXH | Class 2 | General Hospital | No | 2020-03-14 |
| Depressor, Metal Tongue, Surgical | KBL | Class 1 | Ear, Nose, Throat | No | 2020-03-14 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2020-03-14 |
Proprietary Names
Bulb, Inflation, For Endoscope
Water-Based Lubrication
Light, Examination, Medical, Battery Powered
Depressor, Tongue, Non-Surgical
trocar cleaning swab
Disposable Anal
Manual Nebulizer
Plastic Tube
Silicon Tubing;Silicone rubber tubing
Tubing, Pressure And Accessories
Face mask
Camera
Vagina Dilator
Infrared Thermometer
Depressor, Metal Tongue, Surgical
Specimen Collection Flocked Swabs
Establishment Types
Manufacture Medical Device