Data / Medical devices / Hong Kong / SML Med-Tech Solutions Limited
SML Med-Tech Solutions Limited: FDA-registered device maker in Hong Kong, Hong Kong, 1 510(k) clearance
SML Med-Tech Solutions Limited is registered with the FDA (registration 3025347444) in Hong Kong, Hong Kong. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 17, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3025347444
- Address
- Unit 406, Wah Yiu Industrial Centre, 30-32 Au Pui Wan Street Fo Tan, N.T., Hong Kong, Hong Kong, 000000
- Owner or operator
- SML Med-Tech Solutions Limited (10086535)
- Roles
- Manufacturer
- First device listed
- November 17, 2022
- Registered through
- 2026
- Brand names listed
- Air Water Channel Cleaning Adapter- Cerofrict, Disposable Bite Block- Cerofrict, Disposable Endoscope Tip Protector- Cerofrict, Disposable Endoscope Valve Sets, Disposable Endoscope Valve Sets (SML002-LP01), Disposable Polyp Trap- Cerofrict, Disposable Protective Liner- Cerofrict
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Cleaning Brushes, For Endoscope | MNL | 1 | Manufacturer | accessdata.fda.gov |
| Adaptor, Bulbs, Miscellaneous, For Endoscope | FFY | 1 | Manufacturer | accessdata.fda.gov |
| Basin For Endoscope Reprocessing | PHT | 1 | Manufacturer | accessdata.fda.gov |
| Bottle, Collection And Trap, Breathing System (Uncalibrated) | CBC | 2 | Manufacturer | accessdata.fda.gov |
| Endoscope Channel Accessory | ODC | 2 | Manufacturer | accessdata.fda.gov |
| Endoscopic Bite Block | MNK | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 17, 2023 | K220884 | Disposable Endoscope Valve Sets | ODC | Substantially Equivalent | Sml Med-Tech Solutions Limited | accessdata.fda.gov |
Compare with other makers
- All makers of Adaptor, Bulbs, Miscellaneous, For Endoscope
- All makers of Bottle, Collection And Trap, Breathing System (Uncalibrated)
- All makers of Endoscopic Bite Block
- All makers of Basin For Endoscope Reprocessing
- All makers of Endoscope Channel Accessory
- All makers of Accessories, Cleaning Brushes, For Endoscope
Updated January 17, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.