Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013654096

FEI Number

3013654096

Entity Name

MEDICALSYSTEM BIOTECHNOLOGY CO., LTD.

City/State/Country

Ningbo Zhejiang, CN

Establishment Address

No.299, Qiming South Road, Yinzhou District, 315104 Ningbo, China, Ningbo Zhejiang 315104, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MedicalSystem Biotechnology Co., Ltd. (Owner Number: 10055553)

Owner / Operator Contact Address

No.299, Qiming South Road, Yinzhou District, 315104 Ningbo, China, Ningbo, CN-ZJ 315104, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Total Cholesterol Kit (CHOD-PAP Method)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2017-08-10

Official Correspondent

Jihua Zou

US Agent Details

Ryan Workman Business: SD Medical System Inc. Email: ryan.workman@sdmedsys.com Phone: (952) 6931869

Related Public Records

Same Entity

MedicalSystem Biotechnology 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
K790947	Macomb Chemical Co.	AUTO ENZYMATIC CHOLESTEROL	1979-06-28
K885023	Em Diagnostic Systems, Inc.	CHOLESTEROL TEST ITEM NUMBER: SR1011	1989-02-17
K771508	Instrumentation Laboratory CO	MULTISTAT III CHOLESTEROL TEST	1977-09-13

Similar Registrations

Registration Number	Establishment Name	Location
9610529	ROCHE DIAGNOSTICS GMBH	PENZBERG Bavaria, DE
1181121	Fisher Diagnostics	MIDDLETOWN, VA, US
3003795116	ROCHE DIAGNOSTICS INTERNATIONAL LTD.	ROTKREUZ Zug, CH
1423455	HOME ACCESS HEALTH CORP.	Hoffman Est, IL, US
3005644014	VISGENEER, INC.	HSINCHU CITY Hsinchu (City), TW

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013654096. Last updated year: 2026. Please use registration number 3013654096 when referencing this establishment in official correspondence.