Data / Medical devices / Singapore / Advanced Bio Machines Pte. Ltd.
Advanced Bio Machines Pte. Ltd.: FDA-registered device maker in SINGAPORE Central Singapore, Singapore, 3 510(k) clearances
Advanced Bio Machines Pte. Ltd. is registered with the FDA (registration 3017373426) in SINGAPORE Central Singapore, Singapore. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated April 8, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017373426
- Address
- 36 Robinson Road #20-01 City House, SINGAPORE Central Singapore, Singapore, 068877
- Owner or operator
- Advanced Bio Machines Pte. Ltd. (10083610)
- Roles
- Exporter to the US
- First device listed
- December 6, 2021
- Registered through
- 2026
- Brand names listed
- BIWAZE COUGH, BiWaze Clear System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Positive Pressure Breathing, Intermittent | NHJ | 2 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| April 8, 2024 | K231728 | BiWaze Clear System | NHJ | Substantially Equivalent | Abmrc, LLC | accessdata.fda.gov |
| December 21, 2022 | K213564 | BiWaze Clear System | NHJ | Substantially Equivalent | Abmrc, LLC | accessdata.fda.gov |
| March 27, 2020 | K191912 | BiWaze Cough | NHJ | Substantially Equivalent | Abmrc, LLC | accessdata.fda.gov |
Compare with other makers
Updated April 8, 2024. 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.