JILIN HONGYI BIO-TECH CO., LTD.

FDA Device Registration & Listing · Changchun Jilin, CN · Registration 3043127699

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3043127699
FEI Number
3043127699
Entity Name
JILIN HONGYI BIO-TECH CO., LTD.
City/State/Country
Changchun Jilin, CN
Establishment Address
Room 729, 730, 731, Building G1, Phase II, Changchun Beihu Science and Technology Park, Beihu Science and Technology Development Zone, Changchun Jilin 130102, CN
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device
Owner / Operator
Jilin Hongyi Bio-Tech Co., Ltd. (Owner Number: 10094749)
Owner / Operator Contact Address
Room 729, 730, 731, Building G1, Phase II, Changchun Beihu Science and Technology Park, Beihu Science and Technology Development Zone, Changchun, CN-JL 130102, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Acid Ascorbic; Acid Test Fluoride, Chromium/Cr, Copper, Lead, Hg, Iron, Cyanuric acid, pH, Hardness, Total alkalinity, Carbonate root; Total chlorine, Free chlorine, Bromine, Nitrate, Nitrite, hydrogen sulfide, manganese, sulfate, zinc, sodium chloride Creatinine Aflatoxin (Colloidal Gold); Free Radical Test; Lead Test (Colloidal Gold); Lead Test Swab; Test For The Concentration of Ortho-phthalaldehyde Test; Urine Magnesium Test; Urine Salinity Test; Urine Zinc Test; VC Uric Acid Test Urine leukocyte; UTI Test strip; URS-3N test strip Reagent Strips For Water; Zearalenone Quantitative Test (Time-ResolvedfluoroimmunoasSay) B1 Vomitoxin QuantitativeTest (Time-Res Olvedfuoroimmunoassay); Oil Test Strip; Water Test Strips, Alatoxin B1 Quantitative Test (Time-Resolved Fluoroimmunoassay); ph (urinary,non-quantitative); Gastric Aspirate ph test; pH 0-14; Body pH Levels Test Strips to Track and Monitor Your pH Balance Test Strips for Women; dye-indicator, Universal Ph Test Strip (4.5 - 9); Urinary Test Non-Quant., PH; URS-3N test strip, Yummy pH Alkaline Filter pH Paper Test Strips Kit for Results in Seconds with Litmus Paper, pH Scale 4.5-9; pH Testing Strips 120ct; Specific Gravity One step FSH rapid test Salmonella (fluorescence analysis); Salmonella test (colloidal gold); Salmonella test (fluorescence analysis) Male Sperm Count Test Ketone Test Strip; Ketones (urinary, non-quant); Urinary Test Non-Quant., Nitroprusside

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JMA Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) Clinical Chemistry Class 1 862.1095 2025-12-20
JRS Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis) Clinical Chemistry Class 1 862.2050 2025-12-20
JLA Conversion To Creatinine, Creatine Clinical Chemistry Class 1 862.1210 2025-12-20
JXA Kit, Screening, Urine Microbiology Class 1 866.2660 2025-12-20
KNK Acid, Uric, Uricase (Colorimetric) Clinical Chemistry Class 1 862.1775 2025-12-20
LJX Test, Urine Leukocyte Hematology Class 1 864.7675 2025-12-20
LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use Clinical Chemistry Class 1 862.2050 2025-12-20
CEN Dye-Indicator, Ph (Urinary, Non-Quantitative) Clinical Chemistry Class 1 862.1550 2025-12-20
KSL Solution, Copper Sulfate For Specific Gravity Determinations Hematology Class 1 864.9320 2025-12-20
NGA Test, Follicle Stimulating Hormone (Fsh), Over The Counter Clinical Chemistry Class 1 862.1300 2025-12-20
GOO Antisera, Fluorescent, All Globulins, Salmonella Spp. Microbiology Class 2 866.3550 2025-12-20
DFQ Sperm, Antigen, Antiserum, Control Immunology Class 1 866.5800 2025-12-20
JIN Nitroprusside, Ketones (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1435 2025-12-20

Official Correspondent

Hongting Wang

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Jilin Hongyi Bio-Tech Co., Ltd.
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
K830679 Dow Instruments & Reagents, Inc. URIC ACID COLORIMETRIC DETERMINATION 1983-04-06

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0002-2008 Beckman Coulter Inc 1
FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013 Biomerieux Inc 1
PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043127699. Last updated year: 2026. Please use registration number 3043127699 when referencing this establishment in official correspondence.
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