Braincool AB
Lund Skane, SE
BRAINCOOL AB appears in FDA device records in Lund Skane, SE. FDA records list 4 510(k) clearances between and , no PMA records and 2 registered establishments. 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 Braincool AB between 2017 and 2023. The busiest year on record is 2017, with 1. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2017 | 1 |
| 2018 | 1 |
| 2022 | 1 |
| 2023 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3014426939 | 3014426939 | BRAINCOOL AB | Scheelevagen 2, Lund Skane 22381 SE | 2026 | |
| 3014680747 | 3014680747 | BRAINCOOL INC | 441 Defense Highway, Annapolis, MD 21401 US | 2026 | No device listings on this registration |
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