Data / Medical devices / China / Shenzhen Wellcore Well Technology CO., LTD
Shenzhen Wellcore Well Technology CO., LTD: FDA-registered device maker in Shenzhen Guangdong, China, 1 510(k) clearance
Shenzhen Wellcore Well Technology CO., LTD is registered with the FDA (registration 3045063899) in Shenzhen Guangdong, China. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 31, 1997. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3045063899
- Address
- Room 527, Lianfu Huating, No.188 Qingquan Road, YuCui Community, Longhua Street, Longhua District Shenzhen, Shenzhen Guangdong, China, 518110
- Owner or operator
- Shenzhen Wellcore Well Technology CO., LTD. (10095732)
- Roles
- Manufacturer
- First device listed
- April 20, 2026
- Registered through
- 2026
- Brand names listed
- Everness CPAP Nasal Mask Headgear Set, Replacement Short Tube for N20 Series
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Tubing, Pressure And Accessories | BYX | 1 | Manufacturer | accessdata.fda.gov |
| Ventilator, Non-Continuous (Respirator) | BZD | 2 | 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 |
|---|---|---|---|---|---|---|
| July 31, 1997 | K964092 | TMS COMFORT SERIES NASAL CPAP MASK | BZD | Substantially Equivalent | Tiara Medical Systems, Inc. | accessdata.fda.gov |
Compare with other makers
Updated July 31, 1997. 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.