Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030970187

FEI Number

3030970187

Entity Name

ISD MEDITECH SDN. BHD.

City/State/Country

PETALING JAYA Selangor, MY

Establishment Address

3 Jalan PJS 3/2 Taman Medan, PETALING JAYA Selangor 46000, MY

Establishment Type(s)

Repack or Relabel Medical Device,Foreign Private Label Distributor,Manufacture Medical Device

Owner / Operator

ISD MEDITECH SDN. BHD. (Owner Number: 10090673)

Owner / Operator Contact Address

3 Jalan PJS 3/2 Taman Medan, PETALING JAYA, MY-10 46000, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MEDICAL CHART RECORDING PAPER ULTRASOUND PAPER THERMAL PRINT MEDIA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DSF	Recorder, Paper Chart	Cardiovascular	Class 1	870.2810	2024-04-26

Official Correspondent

No official correspondent registered.

US Agent Details

Dennis Ralph Briscoe Business: DERBY STRATEGIES, LLC Email: dennis.briscoe@gmail.com Phone: (435) 5123650

Related Public Records

Same Entity

ISD MEDITECH SDN. BHD.

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
K770946	Instrumentation Laboratory CO	RECORD, MODEL 702, I.L.	1977-07-05

Similar Registrations

Registration Number	Establishment Name	Location
3002519582	BLUMBERG GMBH & CO. KG	Ratingen North Rhine-Westphalia, DE
9610816	Philips Medizin Systeme Boeblingen GmbH	BOEBLINGEN Baden-Wurttemberg, DE
3032916632	BECTON, DICKINSON AND COMPANY	Irvine, CA, US
3016701404	Philips North America LLC	Export, PA, US
3008729547	GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V.	JUAREZ Chihuahua, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030970187. Last updated year: 2026. Please use registration number 3030970187 when referencing this establishment in official correspondence.