Equinox Biotech Co., Ltd.
Manufacturer and brand owner in Shantou, Guangdong, China. 5 device types, 34 products catalogued.
Equinox Biotech Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Visual, Pregnancy Hcg, Prescription Use, Kit, Test, Pregnancy, Hcg, Over The Counter and 3 other device types. 33 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2006.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3005216656 |
| FEI number | 3005216656 |
| DUNS | 545868502 |
| Establishment type | Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 广东伊康纳斯生物医药科技股份有限公司 |
|---|---|
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shantou |
|---|---|
| Province | Guangdong |
| Address | Rongsheng Technological Zone |
| Postal code | 515063 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Kit, Test, Pregnancy, Hcg, Over The Counter | Class 2 | DAVID One Step Home Use Pregnancy Test Strip, 6 Days Ahead Pregnancy Test, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Midstream, Smilereader Pregnancy Test and 12 more | 2006 | 30 |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | Class 1 | DAVID One Step FSH Urine Test | 2018 | 30 |
| Test, Luteinizing Hormone (Lh), Over The Counter | Class 1 | David ONE Step Ovulation Test Strip, David ONE Step Ovulation Test Midstream, David ONE Step Ovulation Test Cassette, DAVID One Step Semi-quantitative Ovulation Test | 2016 | 38 |
| Urine Collection Kit (Excludes Hiv Testing) | Class 1 | David Ovulation Test KIT, DAVID Ovulation & Pregnancy, DAVID Ovulation & Pregnancy Test, David Ovulation AND Pregnancy Test KIT | 2016 | 7 |
| Visual, Pregnancy Hcg, Prescription Use | Class 2 | DAVID One Step Home Use Pregnancy Test Strip, 6 Days Ahead Pregnancy Test, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Midstream, Smilereader Pregnancy Test and 11 more | 2019 | 16 |
Own-Brand Listings
Clearances
No clearance names Equinox Biotech Co., Ltd. as applicant. 3 are held by another company 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 |
|---|---|---|---|---|
| K181551 | 2019-02-22 | LCX | Traditional | Runbio Biotech Co., Ltd. |
| K172627 | 2018-03-28 | LCX | Traditional | Runbio Biotech Co., Ltd. |
| K053236 | 2006-07-18 | LCX | Traditional | Runbio Biotech Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2001 |
|---|---|
| Main products | Molecular biological rapid diagnostic kits, Chemical drugs, Polymer biomedical membranes |
| Certifications | FDA, CE, ISO 13485, ISO 9001, MDSAP |
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.