Data / Medical devices / Hong Kong / Savewo Limited
Savewo Limited: FDA-registered device maker in New Territories, Hong Kong, 1 510(k) clearance
Savewo Limited is registered with the FDA (registration 3017178899) in New Territories, Hong Kong. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 2, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017178899
- Address
- The First & Second Floors, Texaco Road, Tsuen Wan, New Territories, Hong Kong, 266270
- Owner or operator
- SAVEWO LIMITED (10078476)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- October 23, 2020
- Registered through
- 2026
- Brand names listed
- FreshQ Portable Electrolytic Sterilizer, Disinfectant, Savewo 3D Mask, Savewo ClassicMASK, Transkin, Transkin antibacterial adhesive bandage
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Disinfectant, Medical Devices | LRJ | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | N | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use | PYO | 1 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| September 2, 2022 | K221957 | Savewo ClassicMASK | FXX | Substantially Equivalent | Savewo Limited | accessdata.fda.gov |
Compare with other makers
- All makers of Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use
- All makers of Disinfectant, Medical Devices
- All makers of Mask, Surgical
- All makers of Accessory, Surgical Apparel
- All makers of Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua
Updated September 2, 2022. 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.