Data / Medical devices / United States / Bellaire Industry
Bellaire Industry: FDA-registered device maker in Middle Island, NY, United States, 2 510(k) clearances
Bellaire Industry is registered with the FDA (registration 3005064943) in Middle Island, NY, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 7, 2025. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3005064943
- Address
- 11 Heather Ct, Middle Island, NY, United States, 11953
- Owner or operator
- BELLAIRE INDUSTRY (9071294)
- Roles
- Repackager or relabeler
- First device listed
- March 9, 2026
- Registered through
- 2026
- Brand names listed
- E-pen (e-pen), RM STAR EX with RMS Needle, needle, aspiration and injection, disposable - CJN Needle Cartridge
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Repackager or relabeler | accessdata.fda.gov |
| Needle, Aspiration And Injection, Reusable | GDM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Powered Microneedle Device | QAI | 2 | Repackager or relabeler | 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 7, 2025 | K243143 | E-PEN (E-PEN) | QAI | Substantially Equivalent | Bomtech Electronics Co., Ltd. | accessdata.fda.gov |
| December 26, 2024 | K243097 | RM STAR EX with RMS Needle | GEI | Substantially Equivalent | Bomtech Electronics Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Powered Microneedle Device
- All makers of Needle, Aspiration And Injection, Reusable
Updated April 7, 2025. 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.