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 DEVICEPULSE OXIMETER SAT 801DELTA
ESTABLISHMENT NAMEAL GLOBAL CORPORATION (M) SDN BHD
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGC575171246719
BRAND NAMEBITMOS
MEDICAL DEVICE CATEGORYMD 1302 - Monitoring devices of vital physiological parameters
DEVICE GROUPING TYPESYSTEM
DEVICE DESCRIPTIONPULSE OXIMETER IS A MEDICAL DEVICES THAT MONITOR THE LEVEL OF OXYGEN IN A PATIENT'S BLOOD AND ALERT THE HEALTH-CARE WORKER IF OXYGEN LEVELS DROP BELOW SAFE LEVELS,ALLOWING RAPID INTERVENTION. THESE DEVICES ARE ESSENTIAL IN ANY SETTING IN WHICH A PATIENT'S BLOOD OXYGEN LEVELS REQUIRES MONITORING LIKE OPERATIONS, EMERGENCY AND INTENSIVE CARE, AND TREATMENT AND RECOVERY IN HOSPITAL WARD
DEVICE INTENDED PURPOSETHE OXIMETER IS INTENDED FOR CONTINUOUS MONITORING OR SPOT-CHECKING OF FUNCTIONAL ARTERIAL OXYGEN SATURATION (SPO2) AND PULSE RATE OF ADULT, PEDIATRIC OR NEONATAL PATIENTS IN HOSPITALS, INTRA-HOSPITAL TRANSPORT AND HOSPITAL GRADE FACILITIES.
VALIDITY DATE OF REGISTRATION28/12/2018 - 27/12/2023

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1Pulse OximeterSAT 801∆
2Accessories1970
3Accessories2058
4Accessories2059
5Accessories2060
6Accessories3344
7Accessories1173
8Accessories1005
9Accessories1006
10Accessories3629
11Accessories3631
12Accessories1619
13Accessories2282
14Accessories1890
15Accessories3667
16Accessories3666
17Accessories2288
18Accessories2289
19Accessories2290
20Accessories2433
21Accessories3983
22Accessories1645
23Accessories2858
24Accessories2014
25Accessories1927
26Accessories1859
27Accessories2317
28Accessories2918
29Accessories3858
30Accessories3857
31Accessories1860
32Accessories2318
33Accessories1861
34Accessories1862
35Accessories1901
36Accessories2328
37Accessories2319
38Accessories2329
39Accessories2320
40Accessories2330
41Accessories2321
42Accessories2331
43Accessories2411
44Accessories2412
45Accessories2413
46Accessories2601
47Accessories2602
48Accessories2603
49Accessories2604
50Accessories2605
51Accessories2606
52Accessories1863
53Accessories1864
54Accessories2653
55Accessories1895
56Accessories2258
57Accessories1896
58Accessories2365
59Accessories2055
60Accessories2056
61Accessories2057