FDA Registration
Active
🇨🇳 China
MING FAI ENTERPRISE INTERNATIONAL CO., LTD
Reg #: 3007143236
·
FEI: 3007143236
·
Expires 2026
Products
18
Proprietary Names
19
Establishment Types
1
Classifications
18
Registration Details
- Registration Name
- MING FAI ENTERPRISE INTERNATIONAL CO., LTD
- Registration Number
- 3007143236
- FEI Number
- 3007143236
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Unit D3, 8/F, TML Tower, No 3 Hoi Shing Rd, Tsuen Wan, New Territories
- City
- Kowloon, Hong Kong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K852893
Owner / Operator
- Firm Name
- Ming Fai Enterprise International Co., Ltd.
- Operator Number
- 9035380
- Address
- Unit D3, 8/F, TML Tower, No 3 Hoi Shing, Tsuen Wan, New Territories
- City
- Kowloon, Hong Kong
- State
- HK-NOTA
- Postal Code
- -
- Country
- HK
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 |
|---|---|---|---|---|---|
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2007-12-21 |
| Container, I.V. | KPE | Class 2 | General Hospital | No | 2013-11-06 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2010-01-11 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2007-12-21 |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2013-11-06 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2007-12-21 |
| Operating Room Accessories Table Tray | FWZ | Class 1 | General, Plastic Surgery | No | 2010-01-11 |
| Media, Coupling, Ultrasound | MUI | Class 2 | Radiology | No | 2018-01-26 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 1998-04-30 |
| Drape, Surgical, Antimicrobial | KKX | Class 2 | General, Plastic Surgery | No | 2014-05-29 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | Class N | Unknown | No | 2020-03-30 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2010-01-11 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2013-11-06 |
| Microscope, Operating & Accessories, Ac-Powered, Ophthalmic | HRM | Class 1 | General, Plastic Surgery | No | 2017-06-22 |
| Set, I.V. Fluid Transfer | LHI | Class 2 | General Hospital | No | 2013-11-06 |
| Floss, Dental | JES | Class 1 | Dental | No | 2007-12-21 |
| Stretcher, Patient Restraint | NZD | Class 1 | General Hospital | No | 2010-01-11 |
| Personal Protection Kit | PXC | Class 1 | General Hospital | No | 2020-07-16 |
Proprietary Names
ADHESIVE BANDAGE
Vial Decanter
O.R. Table Sheets
Cotton ball / Cotton pad
Equipment Covers (drape /set-up cover)
COTTON SWAB
Sterile Gel
Toothbrush
Drape Surgical
3-Ply Disposable Face Mask
Gel Positioners
Probe Covers
Uro-Catcher
Bottle Decanter
Knob Covers
Transfer Device
DENTAL FLOSS
Safety Straps
Bag Decanter
Establishment Types
Export Device to the United States But Perform No Other Operation on Device