Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017760831

FEI Number

3017760831

Entity Name

Hi-P ELECTRONICS (MALAYSIA) SDN. BHD.

City/State/Country

Kulim Kedah, MY

Establishment Address

No.50,(Lot 1229) Lorong Perusahaan 2A, Kawasan Perusahaan Kulim, Kulim Kedah 09000, MY

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

HI-P ELECTRONICS (MALAYSIA) SDN. BHD. (Owner Number: 10079713)

Owner / Operator Contact Address

No.50,(Lot 1229) Lorong Perusahaan 2A,, Kawasan Perusahaan Kulim, 09000 Kulim, Kedah Darul Aman, Malaysia., Kulim, MY-02 09000, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

c300 The Circadia C200 System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2026-03-02
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2025-02-13
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2025-02-13

Official Correspondent

NURAZRITA ZAKARIA

US Agent Details

Erhan ILHAN Email: erhan@circadia.health Phone: (310) 5261670

Related Public Records

Same Entity

HI-P ELECTRONICS (MALAYSIA) 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
K913749	Edentec Corp.	EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170	1992-07-02
K771407	Research Development Corp.	LUNG VOLUME & PRESSURE MONITOR	1977-08-04
K122223	Philips Medizin Systeme Boeblingen GmbH	NEW: INTELLIVUE CL RESPIRATION POD NEW: SPECIALIZED ASSESSORY: MOBILE CL RESP ATTACHMENT MODIFIED: INTELLIVUE PATIENT MO	2013-04-12
K832250	Litton Medical Electronics	SERVOMED BASIC BEDSIDE UNIT SMA 102-	1984-06-01
K801515	Abbott Medical Electronics Co.	ABBY II PATIENT MONITOR OR VITAL SIGNS M	1980-07-08

Similar Registrations

Registration Number	Establishment Name	Location
3038761440	Corsano Health SA	Plan-les-Ouates Geneve, CH
3016595211	DYNAMIC EMS LTD	Dalgety Bay Fife, GB
3019388613	Masimo Corporation	Irvine, CA, US
3013500228	Amphenol Cable and Interconnect Technologies Asia Pacific Ltd.	Tsimshatsui, Kowloon, HK
3011353843	MASIMO CORPORATION	Irvine, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017760831. Last updated year: 2026. Please use registration number 3017760831 when referencing this establishment in official correspondence.