FDA Registration
Active
🇭🇰 Hong Kong
SML MED-TECH SOLUTIONS LIMITED
Reg #: 3025347444
·
FEI: 3025347444
·
Expires 2026
Products
6
Proprietary Names
7
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- SML MED-TECH SOLUTIONS LIMITED
- Registration Number
- 3025347444
- FEI Number
- 3025347444
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Unit 406, Wah Yiu Industrial Centre, 30-32 Au Pui Wan Street, Fo Tan, N.T.
- City
- Hong Kong
- Country
- HK
Regulatory Submissions
- 510(k) Number
- K220884
Owner / Operator
- Firm Name
- SML Med-Tech Solutions Limited
- Operator Number
- 10086535
- Address
- Unit 406, Wah Yiu Industrial Centre, 30-32 Au Pui Wan Street, Fo Tan, N.T.
- City
- Hong Kong
- State
- HK-NOTA
- Postal Code
- 000000
- Country
- HK
- Correspondent
- TSZ HANG Ko
US Agent
- Business Name
- SHARE INFO INC.
- Contact Name
- Clare Ho
- Address
- 3557 158th St
- City
- Flushing
- State
- NY
- ZIP
- 11358
- Country
- US
- [email protected]
- Phone
- 929 4102964
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Endoscope Channel Accessory | ODC | Class 2 | Gastroenterology, Urology | No | 2023-01-28 |
| Basin For Endoscope Reprocessing | PHT | Class 1 | Gastroenterology, Urology | No | 2022-11-17 |
| Bottle, Collection And Trap, Breathing System (Uncalibrated) | CBC | Class 2 | General Hospital | No | 2022-11-17 |
| Adaptor, Bulbs, Miscellaneous, For Endoscope | FFY | Class 1 | Gastroenterology, Urology | No | 2022-11-17 |
| Endoscopic Bite Block | MNK | Class 1 | Gastroenterology, Urology | No | 2022-11-17 |
| Accessories, Cleaning Brushes, For Endoscope | MNL | Class 1 | Gastroenterology, Urology | No | 2022-11-17 |
Proprietary Names
Disposable Endoscope Valve Sets
Disposable Endoscope Valve Sets (SML002-LP01)
Disposable Protective Liner- Cerofrict
Disposable Polyp Trap- Cerofrict
Disposable Endoscope Tip Protector- Cerofrict
Disposable Bite Block- Cerofrict
Air Water Channel Cleaning Adapter- Cerofrict
Establishment Types
Manufacture Medical Device