Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026260647

FEI Number

3026260647

Entity Name

YASEE BIOMEDICAL INC

City/State/Country

QINGDAO Shandong, CN

Establishment Address

No.9, Xiuyuan road,High-tech Industrial Development Zone, Qingdao, 266112, China, QINGDAO Shandong 266112, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

YASEE BIOMEDICAL INC (Owner Number: 10086785)

Owner / Operator Contact Address

No.9, Xiuyuan road,High-tech Industrial Development Zone, Qingdao, 266112, China, QINGDAO, CN-SD 266112, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

careliving

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2024-09-07
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2024-09-07
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2024-09-07
BYN	Chair, Posture, For Cardiac And Pulmonary Treatment	Anesthesiology	Class 1	868.5365	2022-12-12

Official Correspondent

ALEX LU

US Agent Details

Alex LU Business: BLUE LAND MICHIGAN INC Email: info@med-bridges.com Phone: (614) 5009184

Related Public Records

Same Entity

YASEE BIOMEDICAL 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
K150396	Apex BioTechnology Corp.	Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips	2015-10-14
K150833	Andon Health Co, Ltd.	iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System	2015-12-04
K811074	Reagents Applications, Inc.	GLUCOSE REAGENT-ENZYMATIC-COLOR 500	1981-04-29
K936212	Heraeus Kulzer, Inc.	GLUCOFILM TEST STRIPS	1994-05-10
K103744	Quantimetrix Corp.	DROPPER A1C DIABETES CONTROL	2011-05-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2009	Lifescan Inc	2	One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.
Z-0042-06	Abbott Laboratories Medisense Products	2	FreeStyle FLASH Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0043-06	Abbott Laboratories Medisense Products	2	Tracker Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0044-06	Abbott Laboratories Medisense Products	2	Xceed Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0378-06	Instrumentation Laboratory Co.	2	GEM PREMIER 3000

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026260647. Last updated year: 2026. Please use registration number 3026260647 when referencing this establishment in official correspondence.