MOWANA Auto Duo
PENTAMASTER MEDIQ SDN BHD · General Hospital
Open FDA's page for this record- Third party flag
- Y
- City
- Simpang Ampat
- Advisory committee description
- General Hospital
- Address 1
- Pmt 861, Persiaran Cassia Selatan 6
- Statement or summary
- Summary
- Product code
- FMI
- Zip code
- 14110
- Applicant
- PENTAMASTER MEDIQ SDN BHD
- Decision date
- 2026-09-17
- Decision code
- SESE
- Country code
- MY
- Device name
- MOWANA Auto Duo
- Advisory committee
- HO
- Contact
- Thean Lye Ong
- K number
- K261266
- Date received
- 2026-04-16
- Review advisory committee
- HO
- Postal code
- 14110
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Needle, Hypodermic, Single Lumen
- Medical specialty description
- General Hospital
- Regulation number
- 880.5570
- Device class
- 2
- Registration number
- 3003310007, 3018507299, 3005609751, 3003902757, 3013162291, 3004127962, 3047706961, 3014165712, 3000214934, 3006787036, 3004111573, 3010462274, 3017907716, 3020294761, 3003464075, 2020394, 1836161, 1017768, 3004458481, 3006973666, 3004143450, 3017509841, 2032098, 1319211, 3010872792, 3016884191, 3003916417, 3015727296, 3014479313, 3009853488, 9610847, 3009746425, 2024024, 3003589279, 3011453824, 3019004087, 9614279, 3007007790, 2027487, 1000523114 +414 more
- FEI number
- 3003310007, 3018507299, 3005609751, 3003902757, 3013162291, 3004127962, 3047706961, 3010862763, 3014165712, 3000214934, 3006787036, 3004111573, 3010462274, 3017907716, 3020294761, 3003464075, 2020394, 1017768, 3004458481, 3006973666, 1000112877, 3008002452, 3004143450, 3017509841, 1319211, 3001570557, 3010872792, 3016884191, 3003169040, 3004521048, 1000174591, 3015727296, 3014479313, 3009853488, 3009746425, 2024024, 3003589279, 3011453824, 3019004087, 3007007790 +414 more