Data / Medical devices / Malaysia / BACTIGUARD (South East Asia) Sdn. Bhd.
BACTIGUARD (South East Asia) Sdn. Bhd.: FDA-registered device maker in Penang Science Park Pulau Pinang, Malaysia, 1 510(k) clearance
BACTIGUARD (South East Asia) Sdn. Bhd. is registered with the FDA (registration 3005315793) in Penang Science Park Pulau Pinang, Malaysia. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated February 13, 2015. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3005315793
- Address
- 308 b Jalan Perindustrian Bukit Minyak 18, Penang Science Park Pulau Pinang, Malaysia, 14100
- Owner or operator
- BACTIGUARD (South East Asia) Sdn. Bhd. (10048749)
- Roles
- Manufacturer
- First device listed
- February 23, 2015
- Registered through
- 2026
- Brand names listed
- Medocyn, Neuwater Hydrocyn aqua, Redoxcyn
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 |
|---|---|---|---|---|---|---|
| February 13, 2015 | K142775 | Neuwater TM (HydrocynTM aqua) | FRO | Substantially Equivalent | Vigilenz Medical Devices | accessdata.fda.gov |
Compare with other makers
Updated February 13, 2015. 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.