Data / Medical devices / Malaysia / Ineo Tech Sdn Bhd
Ineo Tech Sdn Bhd: FDA-registered device maker in Bandar Cassia Pulau Pinang, Malaysia, 1 510(k) clearance
Ineo Tech Sdn Bhd is registered with the FDA (registration 3027157158) in Bandar Cassia Pulau Pinang, Malaysia. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 29, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027157158
- Address
- PT5825, Jalan Cassia Selatan 3/11 Taman Perindustrian Batu Kawan, Bandar Cassia Pulau Pinang, Malaysia, 14110
- Owner or operator
- INEO TECH SDN BHD (10087790)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- April 10, 2023
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Radiation Attenuating Medical Glove | OPH | 1 | Manufacturer | accessdata.fda.gov |
| Radiographic Protective Glove | IWP | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Surgeon'S Gloves | KGO | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 29, 2023 | K231973 | PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove | KGO | Substantially Equivalent | Ineo Tech Sdn Bhd | accessdata.fda.gov |
Compare with other makers
Updated September 29, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.