Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012526002

FEI Number

3012526002

Entity Name

WUXI BIOHERMES BIO & MEDICAL TECHNOLOGY CO., LTD.

City/State/Country

Wuxi Jiangsu, CN

Establishment Address

No.136 Mashan Meiliang Road,Binhu, Wuxi Jiangsu 214092, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Wuxi Biohermes Bio & Medical Technology Co., Ltd. (Owner Number: 10051365)

Owner / Operator Contact Address

No.136 Mashan Meiliang Road,Binhu, Wuxi, CN-JS 214092, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K161533

PMA Number

N/A

All Registered Proprietary Names

Insulin-like Growth Factor Binding Protein-1 Test Kit(Colloidal Gold) BioHermes, A1C EZ Glycohemoglobin Analysis System, model A1C EZ 2

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OAM	Immunoassay, Insulin-Like Growth Factor Binding Protein-1	Clinical Chemistry	Class 1	862.1550	2016-03-07
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2017-06-29
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2017-06-29

Official Correspondent

Luo Kimi

US Agent Details

Thomas Tang Email: usagent@cefda.com Phone: (631) 7511103

Related Public Records

Same Entity

Wuxi Biohermes Bio & Medical Technology Co., 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
K872302	Ciba Corning Diagnostics Corp.	MODEL 550 EXPRESS CLINICAL CHEMISTRY ANALYZER	1987-09-08
K920820	Helena Laboratories	MODIFICATION COLUMNMATE	1992-08-17
K991850	Biosafe Laboratories, Inc.	SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC	1999-11-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-06	Abbott Laboratories, Inc	1	ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.
Z-0008-2024	Ortho-Clinical Diagnostics, Inc.	1	Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System (Refurbished) (Product Code 6802914), VITROS 4600 Chemistry System (Product Code 6802445), VITROS 4600 Chemistry System (Refurbished) (Product Code 6900440), VITROS 5600 Integrated System (Product Code 6802413), VITROS 5600 Integrated System (Refurbished) (Product Code 6802915), VITROS XT 3400 Chemistry System (Product Code 6844458), and VITROS XT 7600 Integrated System (Product Code 6844461)
Z-0009-06	Beckman Coulter Inc	1	Synchron LX Systems Version 4.5 Operating Software
Z-0010-06	Abbott Laboratories, Inc	1	ARCHITECT c8000 Analyzer System Processing Module, a fully automated, random access, clinical chemistry analyzer which utilizes spectrophotometry (monochromatic and bichromatic modes of measurement) for photometric based determinations.
Z-0010-2019	Radiometer America Inc	1	ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. It is intended for use in a laboratory environment, near patient or point-of-care setting.

Similar Registrations

Registration Number	Establishment Name	Location
3013143953	Actim Oy Manufacturing Site	Joensuu Pohjois-Karjala, FI
1000212994	ACTIM OY	Espoo Uusimaa, FI
3009335633	DiaSource ImmunoAssays, SA	Louvain-La-Neuve Brabant Wallon, BE
3005360469	ACRO BIOTECH Inc.	Montclair, CA, US
3024463179	ACESO LABORATORIES INC.	Chino, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012526002. Last updated year: 2026. Please use registration number 3012526002 when referencing this establishment in official correspondence.