Data / Medical devices / Spain / Indiba
Indiba: FDA-registered device maker in Sant Quirze del Valles Barcelona, Spain, 6 510(k) clearances
Indiba is registered with the FDA (registration 3010836847) in Sant Quirze del Valles Barcelona, Spain. It lists 3 device types. The FDA files 6 510(k) clearances under its listings, the newest dated January 24, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010836847
- Address
- Moianes, 13, Sant Quirze del Valles Barcelona, Spain, 08192
- Owner or operator
- INDIBA S.A.U. (10053645)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- December 27, 2016
- Registered through
- 2026
- Brand names listed
- INDIBA, INDIBA, S.A.U., Indiba Optimum Cream
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer | accessdata.fda.gov |
| Massager, Vacuum, Radio Frequency Induced Heat | PBX | 2 | Manufacturer | accessdata.fda.gov |
| Media, Electroconductive | GYB | 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 |
|---|---|---|---|---|---|---|
| January 24, 2025 | K241107 | Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); Indiba Diathermia Radiofrequency Activ Device (Activ ACT0309/CT9) | PBX | Substantially Equivalent | Indiba S. A. U. | accessdata.fda.gov |
| January 22, 2025 | K243139 | Reverso Pro System | GEI | Substantially Equivalent | Indiba S. A. U. | accessdata.fda.gov |
| November 20, 2024 | K243164 | INDIBA COMPACT devices | PBX | Substantially Equivalent | Indiba S. A. U. | accessdata.fda.gov |
| November 10, 2021 | K212107 | Reverso | GEI | Substantially Equivalent | Intelis Instruments , Ltd. | accessdata.fda.gov |
| October 3, 2016 | K161458 | Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep Care | PBX | Substantially Equivalent | Indiba USA, Inc. | accessdata.fda.gov |
| March 21, 1979 | K782055 | CREAM, SIGNA | GYB | Substantially Equivalent | Parker Laboratories, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Media, Electroconductive
- All makers of Massager, Vacuum, Radio Frequency Induced Heat
Updated January 24, 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.