Is this your brand? Sign in to claim ownership.

ISD MEDITECH SDN. BHD.

Malaysia·MY-MF-000043531

Last updated September 17, 2026

About

ISD MEDITECH is a Medical Recording Chart Paper & Medical Gels Manufacturer, specializing in producing Medical Chart Paper, Ultrasound Paper, Ultrasound Gel and ECG Gel. Our company is based in Malaysia with MDA registered, GMP, ISO 13485 and CE certified.

From the manufacturer's own website. Source

Information

Country: Malaysia
Address: 3, JALAN PJS 3/2, PETALING JAYA, Malaysia
Website: www.isdmeditech.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +60 18 366 9093
PRRC Contact: CAROL TEO
EUDAMED SRN: MY-MF-000043531
FDA FEI Number: 3030970187
DUNS Number: —

Catalogue (712)

Page 7 of 15

Device	Model / Reference	Registries	Class	Status
BIOCARE iE12A	SK-BC-210150-200RS	EUDAMED	Class I	Active
Cardiette / Cardioline 660 100 26	SK-CA-13025-20BS3	EUDAMED	Class I	Active
ECG Roll (63mm x 30m)	SK-6330/16R3	EUDAMED	Class I	Active
Carewell 1112	SK-21525-16R	EUDAMED	Class I	Active
Mortara 9100-001	SK-MO-5070-200RS	EUDAMED	Class I	Active
Edan Cadence Ms1-01921	ACC-CD11290/150RS1	EUDAMED	Class I	Active
ECG ROLL (215mm X 30m)	SK-21530/16R3	EUDAMED	Class I	Active
Ultrasound Paper 84mm x 13.5m (Standard, Type I) Skymed	SM84S	EUDAMED	Class I	Active
Cardiette / Cardioline 660 100 42	SK-CA-210280-200BS	EUDAMED	Class I	Active
Siemens 9390477 E100e	SK-SS-104100-200RS	EUDAMED	Class I	Active
Cambridge 60-0000-001	ACC-CAM215280/250RS	EUDAMED	Class I	Active
Space Labs 307 568	ACC-SP120150/200S	EUDAMED	Class I	Active
Burdick 7983 / 7984	SK-B215280-200RS1	EUDAMED	Class I	Active
Biosys Bfm-900	SK-BY11225-16B3	EUDAMED	Class I	Active
Nihon Kohden Rqs50-3	ACC+C286:C310-5030/16R3	EUDAMED	Class I	Active
Innomed Ecg Roll 58mm X 25m	SK-5825/16R3	EUDAMED	Class I	Active
ECG Roll (63mm x 30m)	SK-6330/16R4	EUDAMED	Class I	Active
Schiller 2157-023	ACC-S210140/160RS	EUDAMED	Class I	Active
Bionet 152300-005300	ACC-BN21525/16R3	EUDAMED	Class I	Active
Biocare 1200/1215	SK-21030-16R3	EUDAMED	Class I	Active
Kenz R50x30r-C	SK-5030-13R	EUDAMED	Class I	Active
Edan Se-6/Se-12	ACC-21025/16R4	EUDAMED	Class I	Active
Edan Se-3/Se300	ACC-8025/13R3	EUDAMED	Class I	Active
Comen Star5000	ACC-CO15190/150RS	EUDAMED	Class I	Active
ECG Roll (50mm x 45m)	SK-5045/16R	EUDAMED	Class I	Active
Edan Se-1/Se100	SK-5030-16R3	EUDAMED	Class I	Active
Trismed Cardipia 400	SK-11030-16R4	EUDAMED	Class I	Active
Marquette 9402-021	SK-MQ-210280-300R	EUDAMED	Class I	Active
Fukuda Cardisunny 501a/501b	SK-5030-16R3	EUDAMED	Class I	Active
Sky GEL ECG Gel 260E	SKYGEL260E	EUDAMED	Class I	Active
Kenz R50x30r-C	SK-5030-13R4	EUDAMED	Class I	Active
Biocare 3030/6010	SK-11230-16R3	EUDAMED	Class I	Active
Huntleigh Bd4000xs/Bd4002	ACC-HT210150/200	EUDAMED	Class I	Active
Edan Ms1r-107371-Ao	SK-ED210295-100RS	EUDAMED	Class I	Active
Carewell 1106/Aspel Ascard A4	SK-11230-16R4	EUDAMED	Class I	Active
Edan Se-6/Se-12	SK-21025-16R	EUDAMED	Class I	Active
Schiller 2157-012	ACC-S210140/250GNS	EUDAMED	Class I	Active
Fukuda Cardisuny 063f30-H03 / Op-219te	ACC-FC63100/300RS1	EUDAMED	Class I	Active
ECG Roll (112mm x 30m)	SK-11230/16R3	EUDAMED	Class I	Active
Physio-Control Lifepack 11/12	ACC-10823/16R3	EUDAMED	Class I	Active
Kenz Suzuken P210x48z	ACC-K210150/200RS	EUDAMED	Class I	Active
Hellige Marquette 2261 6802	SK-9030-16R3	EUDAMED	Class I	Active
Ultrasound Paper 210mm x 25m (High Glossy, Type V) Skymed	SM210HG	EUDAMED	Class I	Active
Fukuda Cardisuny 050r30-F01	ACC-5030/16R3	EUDAMED	Class I	Active
Biocare 1200/1215	SK-21030-16R4	EUDAMED	Class I	Active
Biocare 100/100g	SK-5030-16R4	EUDAMED	Class I	Active
ECG Roll (100mm x 25m)	SK-10025/16RS4	EUDAMED	Class I	Active
Biocare 300/300g	SK-6030-16R	EUDAMED	Class I	Active
Ultrasound Paper 84mm x 12.5m (High Glossy, Type V) ACCU-PLUS	ACC-84HG	EUDAMED	Class I	Active
Space Labs Ms1r-107371-Ao	ACC-SP210295/100RS	EUDAMED	Class I	Active

Related Companies

Authorised Representatives

MDSS GmbH DE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.