Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004832480

FEI Number

3004832480

Entity Name

SUPERCOMAL MEDICAL PRODUCTS, SDN BHD

City/State/Country

SUNGAI PETANI Kedah, MY

Establishment Address

LOT 171,JALAN PKNK 3/8,KAWASAN, PERUSAHAAN, SUNGAI PETANI, SUNGAI PETANI Kedah 08000, MY

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SUPERCOMAL MEDICAL PRODUCTS, SDN BHD (Owner Number: 9065891)

Owner / Operator Contact Address

LOT 172,JALAN PKNK 3/8,KAWASAN, PERUSAHAAN, SUNGAI PETANI, SUNGAI PETANI, KEDAH D.A., MY-NOTA 08000, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

EV1000 Clinical Platform With ClearSight Finger Cuff Or ClearSight System, EV1000 Clinical Platform TruWave Disposable Pressure Transducer Cable EDSLAB Closed Injectate Delivery System Cable Model VIG2 Monitor Cable Ambu Neuroline Monopolar Cable Ambu Neuroline Concentric Cable VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR, MODELS MIHM1 AND MIHM1P Beautiful Image Body Sculpting Model 900 CBL CO-Set Injectate Temp Probe LOA EV1000 Clinical Platfom Cable

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2016-12-21
DSB	Plethysmograph, Impedance	Cardiovascular	Class 2	870.2770	2016-12-21
DXO	Transducer, Pressure, Catheter Tip	Cardiovascular	Class 2	870.2870	2015-10-31
KRB	Probe, Thermodilution	Cardiovascular	Class 2	870.1915	2015-10-31
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2015-10-31
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2020-05-12
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2019-04-30
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2019-04-30
NFO	Stimulator, Transcutaneous Electrical, Aesthetic Purposes	Neurology	Class 2	882.5890	2020-06-30
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2017-08-01
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2015-10-31

Official Correspondent

No official correspondent registered.

US Agent Details

SHEPARD BENTLEY Business: BENTLEY BIOMEDICAL CONSULTING, LLC. Email: shepbentley@aol.com Phone: (949) 4954274

Related Public Records

Same Entity

SUPERCOMAL MEDICAL PRODUCTS, 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
K100940	Andon Health Co, Ltd.	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965	2010-06-29
K251581	Shenzhen Hingmed Medical Instrument Co., Ltd.	Wearable Ambulatory Blood Pressure Monitor (WBP-02A)	2026-02-13
K200521	Health & Life Co., Ltd.	Full Automatic(NIBP) Blood Pressure Monitor	2020-06-12
K152003	Andon Health Co, Ltd.	iHealth BP3L Wireless Blood Pressure Monitor	2015-09-24
K952827	Sein Electronics Co., Ltd.	FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000	1996-11-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0032-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.
Z-0020-2025	Philips North America Llc	2	IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062; 3) IntelliVue MX500 866064; 4) IntelliVue MX550 866066 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
Z-1027-2026	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. USB 2-Channel IBP Module, REF: 01-2017. Used with User/Operator Manual

Similar Registrations

Registration Number	Establishment Name	Location
1062836	DIGICARE BIOMEDICAL TECHNOLOGY, INC.	BOYNTON BEACH, FL, US
3006543075	SHANGHAI KODEA ECONOMIC AND TRADE DEVELOPMENT LIMI	SHANGHAI, CN
3011912849	BODYTRACE	San Jose, CA, US
3036999955	ZYBS CONSULTING LLC DBA ZYBS MEDICAL GROUP, DBA ZYBS MEDICAL	Largo, MD, US
3019575688	AKTIIA SA	Neuchatel, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004832480. Last updated year: 2026. Please use registration number 3004832480 when referencing this establishment in official correspondence.