Data / Medical devices / Portugal / K Line Portugal Unipessoal Ltd
K Line Portugal Unipessoal Ltd: FDA-registered device maker in Chaves Braga, Portugal, 1 510(k) clearance
K Line Portugal Unipessoal Ltd is registered with the FDA (registration 3033492726) in Chaves Braga, Portugal. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 16, 2022. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3033492726
- Address
- Estrada de Braga, Lugar de S.Fausto, Armazem 4, Chaves Braga, Portugal, 5400-283
- Owner or operator
- K LINE EUROPE GMBH (10079939)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- January 5, 2021
- Registered through
- 2026
- Brand names listed
- CLEAR X, K Clear
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aligner, Bracket, Orthodontic | ECQ | 1 | Manufacturer | accessdata.fda.gov |
| Aligner, Sequential | NXC | 2 | Complaint file establishment, Contract manufacturer, Manufacturer, 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 |
|---|---|---|---|---|---|---|
| March 16, 2022 | K220726 | K Clear | NXC | Substantially Equivalent | Kline Europe GmbH | accessdata.fda.gov |
Compare with other makers
Updated March 16, 2022. 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.