BiometerPlus USA, Inc.

FDA Device Registration & Listing · Fremont, CA, US · Registration 3010830834

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
3010830834
FEI Number
3004525092
Entity Name
BiometerPlus USA, Inc.
City/State/Country
Fremont, CA, US
Establishment Address
48531 Warm Springs Blvd., #416, Fremont, CA 94539, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
BiometerPlus USA, Inc. (Owner Number: 10046647)
Owner / Operator Contact Address
48531 Warm Springs Blvd., #416, Fremont, CA 94539, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

Q.STEPS Glucose/Cholesterol/Uric Acid Monitoring System BIO Dental Radiographic Film BIO TAPE and BANDAGE BIO Peak Flow Meter BIO-S30032138LL, disposable syringes Luer Lock with needles, 3 ml, 21G x 38mm BIO-S30102036LL, disposable syringes Luer Lock with needles, 10 ml, 20G x 36mm BIO-V052713, Vaccination Syringes, 0.5 ml, 20G x 32mm, 27G x 13mm BIO-S30052038LL, disposable syringes Luer Lock with needles, 5 ml, 20G x 38mm BIO-S30202038LL, disposable syringes Luer Lock with needles, 20 ml, 20G x 38mm BIO-S30032232LL, disposable syringes Luer Lock with needles, 3 ml, 22G x 32mm BIO-S30032325LL, disposable syringes Luer Lock with needles, 3 ml, 23G x 25mm BIO-V052325, Vaccination Syringes, 0.5 ml, 20G x 32mm, 23G x 25mm BIO-V052032, Vaccination Syringes, 0.5 ml, 20G x 32mm, 22G x 32mm BIO-V102516, Vaccination Syringes, 1 ml, 20G x 32mm, 25G x 16mm BIO-S30052132LL, disposable syringes Luer Lock with needles, 5 ml, 21G x 32mm BIO-S30102132LL, disposable syringes Luer Lock with needles, 10 ml, 21G x 32mm BIO-S30032038LL, disposable syringes Luer Lock with needles, 3 ml, 20G x 38mm BIO-S30102032LL, disposable syringes Luer Lock with needles, 10 ml, 20G x 32mm BIO-S3003LL, 3-part disposable syringes Luer Lock, 3 ml BIO-S3005LL, 3-part disposable syringes Luer Lock, 5 ml BIO-S3020LL, 3-part disposable syringes Luer Lock, 20 ml BIO-S3010LL, 3-part disposable syringes Luer Lock, 10 ml JOFRI-GSL800S, Gloves surgery latex, sterile, and disposable. Size 8, pair JOFRI-GSL712S, Gloves surgery latex, sterile, and disposable. Size 7 1/2, pair JOFRI-GELMNS, Gloves examination, latex, non sterile, ambidextrous, disposable. Medium size JOFRI-GELLS, Gloves examination, latex, none sterile, ambidextrous, disposable. Large size JOFRI-GELMS, Gloves examination, latex, sterile, ambidextrous, disposable. Medium size JOFRI-GELSNS, Gloves examination, latex, non sterile, ambidextrous, disposable. Small size JOFRI-GEPMS, Gloves examintaion, polyethylene, sterile, ambidextrous, disposabe. Medum size JOFRI-GSL812S, Gloves surgery latex, sterile, and disposable. Size 8 1/2, pair JOFRI-GELLS, Gloves examination, latex, sterile, ambidextrous, disposable. Large size JOFRI-GSL612S, Gloves surgery latex, sterile and disposable. Size 6 1/2, pair JOFRI-GSL700S, Gloves surgery latex, sterile, and disposable. Size 7, pair JOFRI-GEPLS, Gloves examintaion, polyethylene, sterile, ambidextrous, disposabe. Large size JOFRI-GELSS, Gloves examination, latex, sterile, ambidextrous, disposable. Small size BIO-N1832, Hypodermic needles, 18G x 32mm BIO-N2032, Hypodermic needles, 20G x 32mm BIO-N2132, Hypodermic needles, 21G x 32mm BIO-N2325, Hypodermic needles, 23G x 25mm BIO-N2232, Hypodermic needles, 22G x 32mm BIO-N2038, Hypodermic needles, 20G x 38mm BIO-N2138, Hypodermic needles, 21G x 38mm BIO-N2516, Hypodermic needles, 25G x 16mm BIO-N2713, Hypodermic needles, 27G x 13mm BIO-N2238, Hypodermic needles, 22G x 38mm BIO Aseptic Irrigation Syringe Q.STEPS Cholesterol Meter System Q.Steps G/C Monitoring system(Glucose/TC); Q.Steps Glucose Meter system BIO Toothbrush BIO-053108, Insulin syringes, 0.5 ml 31G x 8mm, 0 to 50 units BIO-I102713, Insulin syringes, 1 ml, 27G x 13mm, 0 to 100 units Q. CHECK ALL-IN-1 HEALTH MONITORING SYSTEM (Glucose, Uric Acid, Total Cholesterol, Triglyceride, HDL & LDL) Q.CHECK LPTs 3-in-1 METER SYSTEM(TC/TG/HDL/Cal LDL)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
CHD Acid, Ferric Ion-Sulfuric, Cholesterol Clinical Chemistry Class 1 862.1175 2021-07-22
EGZ Holder, Film, X-Ray Dental Class 1 872.1905 2026-01-13
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2026-01-13
BZH Meter, Peak Flow, Spirometry Anesthesiology Class 2 868.1860 2026-01-13
MEG Syringe, Antistick General Hospital Class 2 880.5860 2024-11-14
FMF Syringe, Piston General Hospital Class 2 880.5860 2024-11-14
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-04-25
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-04-25
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2024-11-14
LBT Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl Clinical Chemistry Class 1 862.1475 2025-04-30
JIS Calibrator, Primary Clinical Chemistry Class 2 862.1150 2026-01-13
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2022-01-01
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2022-01-01
EFW Toothbrush, Manual Dental Class 1 872.6855 2026-01-13
MEG Syringe, Antistick General Hospital Class 2 880.5860 2024-11-14
FMF Syringe, Piston General Hospital Class 2 880.5860 2024-11-14
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2014-04-21
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2014-04-21
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2014-04-21
CHH Enzymatic Esterase--Oxidase, Cholesterol Clinical Chemistry Class 1 862.1175 2014-04-21

Official Correspondent

Jian Zhou

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BiometerPlus USA, 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
K843874 Beiersdorf, Inc. LEUKOPOR SURGICAL TAPE 1985-02-21
K915446 Sun Glitz Corp. STRETCH WRAP 1992-05-06
K833120 Acme United Corp. ONE TIME COMPOUND BENZOIN TINCTURE- 1983-12-29
K870091 Avery Intl. IV SECUREMENT DEVICE USING PCCE THERMO. FILM 1987-02-04
K050853 Card Guard Scientific Survival , Ltd. PMP4 SPIROPRO 2005-05-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-04 Liberty Medical Supplies 2
Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04 Liberty Medical Supplies 2
Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04 Liberty Medical Supplies 2
Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024 Fresenius Medical Care Holdings, Inc. 2
10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024 Fresenius Medical Care Holdings, Inc. 2
10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010830834. Last updated year: 2026. Please use registration number 3010830834 when referencing this establishment in official correspondence.
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