Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8043510

FEI Number

3003335291

Entity Name

K-JUMP HEALTH CO., LTD.

City/State/Country

New Taipei City, TW

Establishment Address

No 56, Wu Kung 5th Rd., New Taipei Industrial Park, New Taipei City 24890, TW

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

K-JUMP HEALTH CO., LTD. (Owner Number: 9002077)

Owner / Operator Contact Address

No. 56, Wu Kung 5th Rd., New Taipei Industrial Park, New Taipei City, TW-NOTA 24890, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Walgreens

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2005-08-16
SDV	Clinical Electronic Thermometer	General Hospital	Class 2	880.2910	2025-07-08
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2009-10-20
KIA	Cover, Cast	General Hospital	Class 1	880.6185	2017-12-01
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2009-07-22
CEP	Radioimmunoassay, Luteinizing Hormone	Clinical Chemistry	Class 1	862.1485	2024-08-12

Official Correspondent

No official correspondent registered.

US Agent Details

Stan Cohen Business: POLYGREEN USA LLC Email: stan@180innovations.com Phone: (303) 2710300

Related Public Records

Same Entity

K-JUMP HEALTH CO., LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3001034529	POLYGREEN (HK) CO., LTD.	Kowloon Hong Kong, CN
3033482477	K-JUMP HEALTH CO., LTD. RENDE PLANT	Tainan City, TW
3003829675	DONGGUAN POLYGREEN TECHNOLOGY CO., LTD.	DONGGUAN Guangdong, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K163485	Adherium (Nz), Ltd.	SmartTouch	2017-08-30
K781467	Travenol Laboratories, S.A.	U-FLOAT VALVE 2D9023	1978-09-07
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

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.

Similar Registrations

Registration Number	Establishment Name	Location
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3018783526	CEVA LOGISTICS NETHERLANDS BV (Venray)	Oostrum Limburgh, NL
3005998497	SUNMED AP, LTD.	ZHUHAI Guangdong, CN
3006852037	Omron Healthcare Manufacturing Vietnam Co., Ltd.	Ho Chi Minh City, VN
3006783791	GaleMed (Xiamen) Co., Ltd.	XIAMEN Fujian, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8043510. Last updated year: 2026. Please use registration number 8043510 when referencing this establishment in official correspondence.