Data / Medical devices / Portugal
Medical device makers in Portugal: 14 FDA-registered establishments
14 establishments in Portugal are registered with the FDA to make medical devices for the US market, listing 23 device types. 5 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- PortugalCountry
Device types made here
Device types with the most registered makers in this country.
| Device | Product code | Makers |
|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 |
| System, Image Processing, Radiological | LLZ | 2 |
| Exerciser, Measuring | ISD | 2 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 1 |
| Accessories, Arthroscopic | NBH | 1 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | 1 |
| Implant, Endosseous, Root-Form | DZE | 1 |
| Abutment, Implant, Dental, Endosseous | NHA | 1 |
| Accessories, Implant, Dental, Endosseous | NDP | 1 |
| Tubes, Gastrointestinal (And Accessories) | KNT | 1 |
| Tube, Feeding | FPD | 1 |
| Garment, Protective, For Incontinence | EYQ | 1 |
| Tray, Surgical, Instrument | FSM | 1 |
| Vibrator For Therapeutic Use, Genital | KXQ | 1 |
| Catheter, Umbilical Artery | FOS | 1 |
| Handpiece, Air-Powered, Dental | EFB | 1 |
| Controller, Foot, Handpiece And Cord | EBW | 1 |
| Aid, Transfer | IKX | 1 |
| Frame, Spectacle | HQZ | 1 |
| Lens, Spectacle (Prescription), For Reading Discomfort | NJH | 1 |
| Lift, Patient, Non-Ac-Powered | FSA | 1 |
| Aligner, Sequential | NXC | 1 |
| Aligner, Bracket, Orthodontic | ECQ | 1 |
Makers in Portugal
Best documented first: most 510(k) clearances and PMA approvals.
| Maker | Location | Device types | 510(k) clearances | PMA approvals | Recall events | Source |
|---|---|---|---|---|---|---|
| Vygon Portugal | Balter-Paredes Porto, Portugal | 4 | 8 | 0 | 0 | api.fda.gov |
| AI4MedImaging Medical Solutions S.A. | Braga, Portugal | 2 | 2 | 0 | 0 | api.fda.gov |
| Bien-Air Portugal Unipessoal LDA | Maia Porto, Portugal | 2 | 1 | 0 | 0 | api.fda.gov |
| K Line Portugal Unipessoal Ltd | Chaves Braga, Portugal | 2 | 1 | 0 | 0 | api.fda.gov |
| Peek Health, S.A. | Braga, Portugal | 2 | 1 | 0 | 0 | api.fda.gov |
| Bastos Viegas, S.A. | Penafiel Porto, Portugal | 1 | 0 | 0 | 0 | api.fda.gov |
| Energypulse Systems | Lisboa, Portugal | 1 | 0 | 0 | 0 | api.fda.gov |
| Hydrumedical, S.A. | Barco Braga, Portugal | 1 | 0 | 0 | 0 | api.fda.gov |
| Impetus Portugal - Texteis, S.A. | Barqueiros Braga, Portugal | 1 | 0 | 0 | 0 | api.fda.gov |
| Invacare Portugal, Lda | Leca do Balio Porto, Portugal | 3 | 0 | 0 | 0 | api.fda.gov |
| LX Precision Portugal, Unipessoal, Lda | Castelo de Paiva Aveiro, Portugal | 3 | 0 | 0 | 0 | api.fda.gov |
| Sword Health S.A. | Vila Nova de Gaia Porto, Portugal | 1 | 0 | 0 | 0 | api.fda.gov |
| Sword Health S.A. | Porto, Portugal | 2 | 0 | 0 | 0 | api.fda.gov |
| Shamir Portugal | VCD Porto, Portugal | 2 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.