Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015413132

FEI Number

3015413132

Entity Name

EAGLENOS SCIENCES, INC.

City/State/Country

Nanjing Jiangsu, CN

Establishment Address

B2-2, Treehouse Headquarters Cluster, No.73 Tanmi Road, Nanjing Jiangbei New Area, Nanjing Jiangsu 210044, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

EAGLENOS SCIENCES, INC. (Owner Number: 10083191)

Owner / Operator Contact Address

B2-2, Treehouse Headquarters Cluster, No.73 Tanmi Road Jiangbei New Area, Nanjing, CN-JS 210044, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LFQ	Acid, Uric, Acid Reduction Of Ferric Ion	Clinical Chemistry	Class 1	862.1775	2021-11-02
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2021-11-02
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2021-11-01
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2023-11-20

Official Correspondent

Tingting Xu

US Agent Details

Joshua Doverspike Business: Eaglenos Sciences USA, Inc. Email: doverspike_joshua@eaglenos.com Phone: (814) 4945204

Related Public Records

Same Entity

EAGLENOS SCIENCES, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K790947	Macomb Chemical Co.	AUTO ENZYMATIC CHOLESTEROL	1979-06-28
K885023	Em Diagnostic Systems, Inc.	CHOLESTEROL TEST ITEM NUMBER: SR1011	1989-02-17
K771508	Instrumentation Laboratory CO	MULTISTAT III CHOLESTEROL TEST	1977-09-13

Similar Registrations

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3004145393	TAIDOC TECHNOLOGY CORPORATION	New Taipei City, TW
3003902721	HMD BIOMEDICAL, INC.	Hsinchu County, TW
3007301207	CHUNGDO PHARM. CO., LTD.	Chuncheon-si Gangwon, KR
3014353121	VIDAN DIAGNOSTICS, LLC	San Antonio, TX, US
1649661	GERMAINE LABORATORIES, INC.	SAN ANTONIO, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015413132. Last updated year: 2026. Please use registration number 3015413132 when referencing this establishment in official correspondence.