Solaris Medical Technology, Inc.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 3 device types, 4 products catalogued, 5 clearances.
Solaris Medical Technology, Inc. is a manufacturer holding a current FDA establishment registration. The registration covers Oximeter, Cable, Electrode and 1 other device type. 4 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2008.
3device types registered with the FDA
4products catalogued under its own name
5510(k) clearances
Registration
| Registered name | SOLARIS MEDICAL TECHNOLOGY, INC. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3006552505 |
| FEI number | 3006552505 |
| DUNS | 527945351 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 深圳市索莱瑞医疗技术有限公司 |
|---|---|
| Unified social credit code | 914403007488778140 |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | Zhongjian Industrial Building One #401 |
| Postal code | 518067 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Blood Pressure Cuff | Class 2 | Solaris | 2011 | 50 |
| Cable, Electrode | Class 2 | Solaris | 2023 | 47 |
| Oximeter | Class 2 | Solaris | 2008 | 70 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Solaris | DQA | 6 |
| Solairs | DQA | 4 |
| Oximeter | DQA | 1 |
| Avante/Pacific | DQA | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K100077 | 2010-10-07 | DQA | Traditional | This company |
| K101972 | 2010-07-22 | DXQ | Traditional | This company |
| K092950 | 2010-03-12 | DQA | Special | This company |
| K073249 | 2008-07-25 | DQA | Traditional | This company |
| K061931 | 2007-01-31 | DQA | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2002 (US), 2003 (China facility) |
|---|---|
| Main products | SpO2 probes, ECG cables, NIBP cuffs |
| Certifications | ISO 13485, FDA, CE |
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.
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