Data / Medical devices / Tunisia / Plastic Electromechanic Company Medical Device
Plastic Electromechanic Company Medical Device: FDA-registered device maker in Bir Mcherga Zaghouan, Tunisia, 2 510(k) clearances
Plastic Electromechanic Company Medical Device is registered with the FDA (registration 3042888450) in Bir Mcherga Zaghouan, Tunisia. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 13, 2005. 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
- 3042888450
- Address
- Lot 14, Zone industrielle 3, Djebel El Oust, 1141 Bir Mcherga, Zaghouan - Tunisie, Bir Mcherga Zaghouan, Tunisia, 1141
- Owner or operator
- Plastic Electromechanic Company Medical Device (10094737)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 19, 2025
- Registered through
- 2026
- Brand names listed
- CLARAVUE, SPIRO-BALL, TRI-BALL
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Electrocardiograph | DRX | 2 | Contract manufacturer | accessdata.fda.gov |
| Spirometer, Therapeutic (Incentive) | BWF | 2 | 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 13, 2005 | K053149 | SPIRO-BALL | BWF | Substantially Equivalent | Leventon, S.A. | accessdata.fda.gov |
| June 8, 2000 | K994074 | TRI-BALL | BWF | Substantially Equivalent | Leventon, S.A. | accessdata.fda.gov |
Compare with other makers
Updated December 13, 2005. 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.