Shenzhen Wellcore Well Technology Co., Ltd.
Registered establishment in Shenzhen, Guangdong, China. 2 device types.
Shenzhen Wellcore Well Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Ventilator, Non-Continuous (Respirator), Attachment, Breathing, Positive End Expiratory Pressure. Its earliest product listing with the FDA dates from 2026.
Registration
| Registered name | Shenzhen Wellcore Well Technology CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3045063899 |
| FEI number | 3045063899 |
| Establishment type | Manufacturer |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | Room 527, Lianfu Huating, No.188 Qingquan Road, YuCui Community, Longhua Street, Longhua District Shenzhen |
| Postal code | 518110 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Attachment, Breathing, Positive End Expiratory Pressure | Class 2 | Everness CPAP Mask, Full Face Cushion Headgear Frame Set | 2026 | 9 |
| Ventilator, Non-Continuous (Respirator) | Class 2 | Everness CPAP Nasal Mask Headgear Set | 2026 | 18 |
Clearances
No clearance names Shenzhen Wellcore Well Technology Co., Ltd. as applicant. 2 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K964092 | 1997-07-31 | BZD | Traditional | Tiara Medical Systems, Inc. |
| K894690 | 1989-09-08 | BYE | Traditional | Devilbiss Health Care, Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2006 |
|---|---|
| Employees | 150+ |
| Factory area | 1,200+ square meters |
| Main products | SSD, Ibeacon, embedded storage devices |
| Certifications | CE, FCC, RoHS, Alliance |
| Export markets | enterprise, industrial, aerospace |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.