ROSSMAX INTERNATIONAL LTD.

FDA Device Registration & Listing · TAIPEI, TW · Registration 9680548

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
9680548
FEI Number
3003247551
Entity Name
ROSSMAX INTERNATIONAL LTD.
City/State/Country
TAIPEI, TW
Establishment Address
12F., NO.189, KANG CHIEN RD., TAIPEI 114, TW
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
ROSSMAX INTERNATIONAL LTD. (Owner Number: 9009721)
Owner / Operator Contact Address
12 F., NO.189, KANG CHIEN RD.,, --, TAIPEI, TW-TPE 114, TW
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K053006
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2007-11-19
DXQ Blood Pressure Cuff Cardiovascular Class 2 870.1120 2007-11-19
LDE Stethoscope, Manual Cardiovascular Class 1 870.1875 2007-11-19

Official Correspondent

YU-CHIH LIN

US Agent Details

Feng-Yu Lee Business: Dynamic Biotech Inc. Email: fengyulee@ivddreg.com Phone: (949) 2180929

Related Public Records

Same Entity

ROSSMAX INTERNATIONAL 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
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 9680548. Last updated year: 2026. Please use registration number 9680548 when referencing this establishment in official correspondence.
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