Data / Medical devices / Malaysia / V3bio Sdn. Bhd.
V3bio Sdn. Bhd.: FDA-registered device maker in Penang Pulau Pinang, Malaysia, 1 510(k) clearance
V3bio Sdn. Bhd. is registered with the FDA (registration 3026399481) in Penang Pulau Pinang, Malaysia. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 21, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3026399481
- Address
- No.. 18 Jalan Cassia Selatan 3.1, Taman Peridustrian Batu Kawan, 14100, Bandar Cassia, Penang Pulau Pinang, Malaysia, 14100
- Owner or operator
- V3Bio Sdn. Bhd. (10087235)
- Roles
- Manufacturer
- First device listed
- January 31, 2023
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | 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 |
|---|---|---|---|---|---|---|
| December 21, 2022 | K220286 | ELECTROCYN soma | FRO | Substantially Equivalent | V3Bio Sdn. Bhd | accessdata.fda.gov |
Compare with other makers
Updated December 21, 2022. 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.