FDA Registration
Active
🇨🇳 China
Equinox Biotech Co., Ltd.
Reg #: 3005216656
·
FEI: 3005216656
·
Expires 2026
Products
5
Proprietary Names
27
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- Equinox Biotech Co., Ltd.
- Registration Number
- 3005216656
- FEI Number
- 3005216656
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Rongsheng Technological Zone, UNIVERSITY ROAD,
- City
- Shantou Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K181551
Owner / Operator
- Firm Name
- Equinox Biotech Co., Ltd.
- Operator Number
- 9074282
- Address
- No. 12, Gaoxin 2nd Road, Huadu District
- City
- Guangzhou
- State
- Guangdong
- Postal Code
- 510800
- Country
- CN
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Urine Collection Kit (Excludes Hiv Testing) | OIE | Class 1 | Pathology | No | 2016-08-12 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | Class 2 | Clinical Chemistry | No | 2019-04-23 |
| Visual, Pregnancy Hcg, Prescription Use | JHI | Class 2 | Clinical Chemistry | No | 2019-04-23 |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | Class 1 | Clinical Chemistry | No | 2016-04-21 |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | NGA | Class 1 | Clinical Chemistry | No | 2018-01-18 |
Proprietary Names
DAVID OVULATION TEST KIT
DAVID Ovulation & Pregnancy
DAVID OVULATION AND PREGNANCY TEST KIT
DAVID Ovulation & Pregnancy Test
6 Days Ahead Pregnancy Test
DAVID One Step Prescription Pregnancy Test Cassette
Early Blush Pregnancy Test
DAVID One Step Home Use Pregnancy Test Midstream
DAVID One Step Home Use Pregnancy Test Cassette
PREGABLE Pregnancy Test
DAVID One Step Prescription Pregnancy Test Strip
DAVID One Step Home Use Pregnancy Test Strip
Smilereader Pregnancy Test
DAVID One Step Prescription Pregnancy Test Midstream
DAVID Pregnancy Test Strip
DAVID Ovulation & Pregnancy Test Kit
DAVID Pregnancy Test Midstream
DAVID Pregnancy Test
One Step Pregnancy Test
Smilereader pregnancy test
DAVID ONE STEP OVULATION TEST MIDSTREAM
DAVID ONE STEP OVULATION TEST CASSETTE
DAVID ONE STEP OVULATION TEST STRIP
DAVID One Step Semi-quantitative Ovulation Test
David Home Pregnancy Test Cassette
David Professional Pregnancy Test Cassette
DAVID One Step FSH Urine Test
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device