Data / Medical devices / Italy / Igea SPA
Igea SPA: FDA-registered device maker in Carpi (MO) Modena, Italy, 1 PMA approval
Igea SPA is registered with the FDA (registration 9611854) in Carpi (MO) Modena, Italy. It lists 3 device types. The FDA files 1 PMA approval under its listings, the newest dated May 3, 2022. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9611854
- FEI number
- 3002807258
- Address
- Via Parmenide, 10/A, Carpi (MO) Modena, Italy, 41012
- Owner or operator
- IGEA S.p.A. (10025254)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- March 27, 2008
- Registered through
- 2027
- Brand names listed
- 6 Output Oncobionic Generator, AccelStim Bone Growth Stimulator, NanoKnife 3 Generator, NanoKnife 3.5 Generator (P/N H78720300351US0), NanoKnife Generator, NanoKnife Generator (H78720300301 USO);, Onocbionic System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Low Energy Direct Current Thermal Ablation System | OAB | 2 | Contract manufacturer | accessdata.fda.gov |
| Stimulator, Bone Growth, Non-Invasive | LOF | 2 | Manufacturer | accessdata.fda.gov |
| Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue | OCL | 2 | Contract manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| May 3, 2022 | P210035 | AccelStimTM Bone Growth Stimulator | LOF | 2 | March 21, 2025 | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Bone Growth, Non-Invasive
- All makers of Low Energy Direct Current Thermal Ablation System
- All makers of Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
Updated March 21, 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.