This facility is provided to enable any interested parties to search for Registered Medical Device, Registered CAB, Licensed Establishments under Section 5, 10, 15 of Medical Device Act 2012 (Act 737) respectively and Notified Medical Device under Medical Device (Exemption) Order 2016. Any party who wishes to know whether an establishment who is dealing with medical device has been licensed under Act 737 may search the establishment by inserting the establishment name or license number in the searching field below.

DEVICE DETAILS

NAME OF DEVICE	VITROMAP TABLE TOP PULSE OXIMETER
ESTABLISHMENT NAME	TARAF SYNERGY SDN. BHD
ROLE OF ESTABLISHMENT	AUTHORIZED REPRESENTATIVE
REGISTRATION NO	GC641401060818
BRAND NAME	MEDLAB
MEDICAL DEVICE CATEGORY	MD 1100 - GENERAL ACTIVE MEDICAL DEVICES
DEVICE GROUPING TYPE	SYSTEM
DEVICE DESCRIPTION	IT MEASURES AND MONITORS ARTERIAL OXYGEN SATURATION (SPO2) AND PULSE RATE
DEVICE INTENDED PURPOSE	The VITROmap is a table top pulse oximeter. It measures and monitors arterial oxygen saturation (SpO) and pulse rate on patients ranging from pediatric to adults. It is intended for continuous monitoring and data logging in hospital or clinical environments. Any other use is not intended.
VALIDITY DATE OF REGISTRATION	07/03/2023 - 06/03/2028

LIST OF DEVICE

NO	NAME OF DEVICE	IDENTIFIER
1	VITROmap	00840
2	Main adpter GTM410760612	46007
3	P-200 reusable sensor	00535
4	PS-200 reusable sensor	00357
5	PX-200 reusable sensor	00356
6	R-200 reusable sensor	00550
7	RS-200 reusable sensor	00570
8	DIS-200AP disposable sensor	00540
9	DIS-200CP disposable sensor	00541
10	DIS-200IP disposable sensor	00542
11	DIS-200NP disposable sensor	00543
12	SpO2 Extension Cable	00310

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