Hemodia SAS
Labege Haute-Garonne, FR
Hemodia SAS appears in FDA device records in Labege Haute-Garonne, FR. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Hemodia SAS between 2013 and 2023. The busiest year on record is 2013, with 1. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2013 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K221919 | DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets | HRX | Substantially Equivalent | |
| K203480 | DOUBLEFLO system | HRX | Substantially Equivalent | |
| K192921 | Zeos Aqua Vision Pump and tube | HRX | Substantially Equivalent | |
| K132883 | HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS) | HRX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9681574 | 3001137417 | Hemodia SAS | 85 Rue du Chene vert, Labege Haute-Garonne 31670 FR | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain