Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003799895

FEI Number

3003799895

Entity Name

DIGISYSTEM LABORATORY INSTRUMENTS INC.

City/State/Country

New Taipei City, TW

Establishment Address

No.1, Lane 393, FU DE 1 RD., Xizhi Dist, New Taipei City --, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DIGISYSTEM LABORATORY INSTRUMENTS INC. (Owner Number: 9050248)

Owner / Operator Contact Address

NO. 9, LANE 269, FU DE I RD., --, HSI CHIH CITY,TAIPEI, TW-NOTA --, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

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
GHO	Hemocytometer	Hematology	Class 1	864.6160	2015-07-20
GLE	Mixer, Blood Tube	Clinical Chemistry	Class 1	862.2050	2013-01-29
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2002-03-18
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2002-04-11

Official Correspondent

No official correspondent registered.

US Agent Details

LAURA TEMPLETON Business: LW SCIENTIFIC, INC. Email: lauraT@LWScientific.com Phone: (770) 2701394

Related Public Records

Same Entity

DIGISYSTEM LABORATORY INSTRUMENTS INC.

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

Similar Registrations

Registration Number	Establishment Name	Location
3009776283	Attain Technologies BV	Heerhugowaard Noord-Holland, NL
2410251	PROPPER MFG. CO., INC.	Long Island City, NY, US
2518612	HAUSSER SCIENTIFIC CO., INC.	HORSHAM, PA, US
3014053517	BONRAYBIO CO., LTD.	Taichung, TW
3045058049	BOEN HEALTHCARE CO., LTD.	Suzhou Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003799895. Last updated year: 2026. Please use registration number 3003799895 when referencing this establishment in official correspondence.