Senzime AB
Uppsala, SE
SENZIME AB appears in FDA device records in Uppsala, SE. FDA records list 3 510(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 3 510(k) clearances for Senzime AB between 2019 and 2026. The busiest year on record is 2019, with 1. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2019 | 1 |
| 2022 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261098 | TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017) | KOI | Substantially Equivalent | |
| K220530 | Tetragraph Neuromuscular Transmission Monitor | KOI | Substantially Equivalent | |
| K190795 | Tetragraph Neuromuscular Transmission Monitor | KOI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3016490024 | 3016490024 | SENZIME AB | Verkstadsgatan 8, Uppsala 75323 SE | 2026 | |
| 3016560306 | 3016560306 | SENZIME INC. | 748 Hanley Industrial Ct., Saint Louis, MO 63144 US | 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