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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 12 of 15

Device	Model / Reference	Registries	Class	Status
Nihon Kohden Fqs50-2-100	ACC-NK50100/200R	EUDAMED	Class I	Active
Cardiette / Cardioline 660 100 08	SK-CA-12020-20BS3	EUDAMED	Class I	Active
Mortara 9100-016-50	SK-10823-16R3	EUDAMED	Class I	Active
ECG Roll (90mm x 30m)	SK-9030/16R	EUDAMED	Class I	Active
Quinton 36868-001	SK-Q210300-200RS1	EUDAMED	Class I	Active
Esaote Power 8000	ACC-S210280/200RS80	EUDAMED	Class I	Active
Nihon Kohden Pa9100z	SK-NK-210140-142RS	EUDAMED	Class I	Active
Fukuda Denshi Op-114te	ACC-FD63100/300RS	EUDAMED	Class I	Active
Fukuda Denshi Op-219te/063f30-H03	SK-FC63100-300RS1	EUDAMED	Class I	Active
ECG Roll (215mm x 25m) BIONET C. 2000/3000	SK-BN21525/16R3	EUDAMED	Class I	Active
Kenz R80x30r-C	SK-8025-13R3	EUDAMED	Class I	Active
Sky GEL Ultrasound Transmission Medical Gel 5000B	SKYGEL5000B	EUDAMED	Class I	Active
ECG Roll (108mm x 23m)	SK-10823/16R3	EUDAMED	Class I	Active
Kenz Suzuken R112-27r	ACC-11230/16R4	EUDAMED	Class I	Active
Sky GEL Ultrasound Transmission Medical Gel 260C	SKYGEL260C	EUDAMED	Class I	Active
Trismed Cardipia 800	SK-21525-16R4	EUDAMED	Class I	Active
ECG Roll (50mm x 40m)	SK-5040/16R	EUDAMED	Class I	Active
ECG Roll (80mm x 20m)	SK-8020/13R	EUDAMED	Class I	Active
ECG ROLL (45mm X 30m)	SK-4530/16R4	EUDAMED	Class I	Active
Hellige Marquette 2261 6606	SK-HM-215280-150RS	EUDAMED	Class I	Active
Advance Medical System 31-0410	ACC-AMS120100/150R1	EUDAMED	Class I	Active
Cardiette / Cardioline 874 5554	ACC-CA112100/300RS	EUDAMED	Class I	Active
ECG Roll (60mm x 30m)	SK-6030/16R	EUDAMED	Class I	Active
Schiller 2157-025 (80g)	ACC-S210280/200RS80	EUDAMED	Class I	Active
Kenz Suzuken R183-52z-D	ACC-K183280/200RS	EUDAMED	Class I	Active
Nihon Kohden Rqs145-6a-300	SK-NK-14560-16RS3	EUDAMED	Class I	Active
Ecg Roll 183mm X 30m	ACC-18330/16R4	EUDAMED	Class I	Active
Fukuda Denshi Op-122te	ACC-FD6375/400RS	EUDAMED	Class I	Active
Burdick 78 68	ACC-B215280/200R	EUDAMED	Class I	Active
Mortara 9100-016-50	ACC-10823/16R3	EUDAMED	Class I	Active
MINDRAY PM-9000/PM-8000/PM-7000/VS-800, MEC-1200 VET/BeneView T5/T8/BeneHeart D6	ACC-5020/16R3	EUDAMED	Class I	Active
Schiller 2157-014	SK-S9090-400RS	EUDAMED	Class I	Active
Ultrasound Paper Type I (Standard)	ACC-110S	EUDAMED	Class I	Active
Ecg Roll 50mm X 30m	ACC-5030/16R4	EUDAMED	Class I	Active
Marquette 9402-046	ACC-BR5030/16 (CSO)	EUDAMED	Class I	Active
ECG Roll (210mm x 30m)	SK-21030/16R3	EUDAMED	Class I	Active
Schiller 2157-025	ACC-S210280/200RS	EUDAMED	Class I	Active
Advance Medical System 1142751-012e	SK-AMS-120100-150R	EUDAMED	Class I	Active
Bistos Fs130-120-30r-A	SK-BT-130120-250R	EUDAMED	Class I	Active
Schiller 2157-036	ACC-S210140/180RS	EUDAMED	Class I	Active
Ecg Roll 50mm X 20m	ACC-5020/16R4	EUDAMED	Class I	Active
Cardiette / Cardioline 874 5558	SK-CA-60100-300RS	EUDAMED	Class I	Active
Innomed Hs 112d	ACC-IN11225/16R3	EUDAMED	Class I	Active
ECG ROLL (145mm X 30m)	SK-14530/16R3	EUDAMED	Class I	Active
Hellige Marquette 2261 6702	ACC-HM9090/360RS	EUDAMED	Class I	Active
Cardiette / Cardioline 660 100 40	SK-CA-6075-250RS	EUDAMED	Class I	Active
Biocare Fm-801	ACC-BC112100/160R	EUDAMED	Class I	Active
Hewlett Packard / Philips 40457c/D	SK-P5030-16GY4	EUDAMED	Class I	Active
ECG ROLL (50mm X 40m)	SK-5040/16R3	EUDAMED	Class I	Active
Kenz Suzuken R50x30r-C	ACC-5030/13R4	EUDAMED	Class I	Active

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