CHANGCHUN MERYDI BIO-TECH CO., LTD.

FDA Device Registration & Listing · changchun Jilin, CN · Registration 3038206980

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
3038206980
FEI Number
3038206980
Entity Name
CHANGCHUN MERYDI BIO-TECH CO., LTD.
City/State/Country
changchun Jilin, CN
Establishment Address
Room 302, 304a, Block A, Incubation Building, No. 191, Chaoqun Street, High-tech Development Zone, Changchun C, changchun Jilin 130000, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Changchun Merydi Bio-Tech Co., Ltd. (Owner Number: 10093200)
Owner / Operator Contact Address
Room 302, 304a, Block A, Incubation Building, No. 191, Chaoqun Street, High-tech Development Zone, Changchun C, ??, CN-JL 130000, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KNK Acid, Uric, Uricase (Colorimetric) Clinical Chemistry Class 1 862.1775 2025-04-14
JLA Conversion To Creatinine, Creatine Clinical Chemistry Class 1 862.1210 2025-04-14
JIN Nitroprusside, Ketones (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1435 2025-04-13
NRF Material, Quality Control, Semen Analysis Hematology Class 2 864.8625 2025-04-13
NGE Test, Luteinizing Hormone (Lh), Over The Counter Clinical Chemistry Class 1 862.1485 2025-04-14
IGD Solution, Formol Calcium Pathology Class 1 864.4010 2025-04-14
CEN Dye-Indicator, Ph (Urinary, Non-Quantitative) Clinical Chemistry Class 1 862.1550 2025-04-14
CDM Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1785 2025-04-14
NGA Test, Follicle Stimulating Hormone (Fsh), Over The Counter Clinical Chemistry Class 1 862.1300 2025-04-14
JMA Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) Clinical Chemistry Class 1 862.1095 2025-04-14
JXA Kit, Screening, Urine Microbiology Class 1 866.2660 2025-04-14
LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use Clinical Chemistry Class 1 862.2050 2025-04-14
GOO Antisera, Fluorescent, All Globulins, Salmonella Spp. Microbiology Class 2 866.3550 2025-04-13
JRS Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis) Clinical Chemistry Class 1 862.2050 2025-04-13
DFQ Sperm, Antigen, Antiserum, Control Immunology Class 1 866.5800 2025-04-13
KQO Automated Urinalysis System Clinical Chemistry Class 1 862.2900 2025-04-13

Official Correspondent

Hongting Wang

US Agent Details

Hui Hong Business: ABMED MEDICAL TECHNOLOGY INC Email: info@abmed.us Phone: (303) 8000162

Related Public Records

Same Entity

Changchun Merydi 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
K101852 Iris International Inc., A Division of Iris Iris I CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT 2011-03-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0043-2024 Universal Meditech Inc. 1
One Step Ovulation Test REF 200-01
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 3038206980. Last updated year: 2026. Please use registration number 3038206980 when referencing this establishment in official correspondence.
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