Biox Instruments Co Ltd

FDA Device Registration & Listing · Wuxi Jiangsu, CN · Registration 3007663004

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
3007663004
FEI Number
3007663004
Entity Name
Biox Instruments Co Ltd
City/State/Country
Wuxi Jiangsu, CN
Establishment Address
100 Dicui Road, 530 Building 1, 19th Floor, Binhu District, Wuxi Jiangsu 214072, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
VASOMEDICAL, INC. (Owner Number: 2435300)
Owner / Operator Contact Address
137 Commercial St., Unit 200, Plainview, NY 11803, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K111096
PMA Number
N/A

All Registered Proprietary Names

Biox Model 1305, ARCS Models 1303, 1304, 1306,1307,1308, ARCS Models 1804, 1805, 1806, 1807, 2302, 2303, 2304, 2305, 2306, ARCS

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DSH Recorder, Magnetic Tape, Medical Cardiovascular Class 2 870.2800 2009-05-04
DSH Recorder, Magnetic Tape, Medical Cardiovascular Class 2 870.2800 2013-01-30
DSH Recorder, Magnetic Tape, Medical Cardiovascular Class 2 870.2800 2013-01-30
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2013-01-30

Official Correspondent

Matthew McClure

US Agent Details

Matthew McClure Business: Vasomedical Email: mmcclure@vasomedical.com Phone: (516) 5085835

Related Public Records

Same Entity

VASOMEDICAL, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
2435300 VASOMEDICAL, INC. Plainview, NY, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K100940 Andon Health Co, Ltd. FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965 2010-06-29
K251581 Shenzhen Hingmed Medical Instrument Co., Ltd. Wearable Ambulatory Blood Pressure Monitor (WBP-02A) 2026-02-13
K200521 Health & Life Co., Ltd. Full Automatic(NIBP) Blood Pressure Monitor 2020-06-12
K152003 Andon Health Co, Ltd. iHealth BP3L Wireless Blood Pressure Monitor 2015-09-24
K952827 Sein Electronics Co., Ltd. FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000 1996-11-14

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0032-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007663004. Last updated year: 2026. Please use registration number 3007663004 when referencing this establishment in official correspondence.
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