FDA Registration
Active
🇨🇳 China
EAGLENOS SCIENCES, INC.
Reg #: 3015413132
·
FEI: 3015413132
·
Expires 2026
Products
4
Proprietary Names
12
Establishment Types
1
Classifications
4
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Registration Details
- Registration Name
- EAGLENOS SCIENCES, INC.
- Registration Number
- 3015413132
- FEI Number
- 3015413132
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- B2-2, Treehouse Headquarters Cluster, No.73 Tanmi Road, Nanjing Jiangbei New Area
- City
- Nanjing Jiangsu
- Country
- CN
Owner / Operator
- Firm Name
- EAGLENOS SCIENCES, INC.
- Operator Number
- 10083191
- Address
- B2-2, Treehouse Headquarters Cluster, No.73 Tanmi Road Jiangbei New Area
- City
- Nanjing
- State
- Jiangsu
- Postal Code
- 210044
- Country
- CN
- Correspondent
- Tingting Xu
US Agent
- Business Name
- Eaglenos Sciences USA, Inc.
- Contact Name
- Joshua Doverspike
- Address
- 3928 Varsity Dr
- City
- Ann Arbor
- State
- MI
- ZIP
- 48108
- Country
- US
- [email protected]
- Phone
- 814 4945204
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Acid, Uric, Acid Reduction Of Ferric Ion | LFQ | Class 1 | Clinical Chemistry | No | 2021-11-02 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2021-11-02 |
| Acid, Lactic, Enzymatic Method | KHP | Class 1 | Clinical Chemistry | No | 2021-11-01 |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | Class 1 | Clinical Chemistry | No | 2023-11-20 |
Proprietary Names
EAGLENOS Uric Acid Meter, model: BG30, BG31
EAGLENOS Uric Acid Control Solutions
EAGLENOS Uric Acid Test Strips, model: iU100, iU200
EAGLENOS Blood ?-Ketone Test Strips, model: EN500R5, EN500R6
EAGLENOS ?-Ketone Control Solutions(2.5mL/bottle, 2 bottles/box)
EAGLENOS Blood ?-Ketone Meter, model: EN500, EN501, EN502, EN503
EAGLENOS Lactate Test Strips, model: iL100, iL200
EAGLENOS Lactate Meter, model: BG20, BG21
EAGLENOS Lactate Control Solutions
EAGLENOS, Total Cholesterol Solutions
EAGLENOS, Total Cholesterol Test Strips, iC100, iC200
EAGLENOS, Total Cholesterol Meter, EN600, EN601, EN602, EN603, EN604, EN605
Establishment Types
Manufacture Medical Device