Senzime AB
Sweden SE-MF-000016903 Last updated 25 Oct 2026
- Devices
- 16
- Registries
- EUDAMEDFDA 510(k)GUDIDFDA
- FDA recalls
- 0
Catalogue
TetraGraph Xcom Ref SEN 2010
ExSpiron Pediatric PadSets Ref RMI-53040
TetraSens Electrode Ref SEN 2002
TetraHub Ref SEN 2017
ExSpiron Adult PadSets Ref RMI-51110
Tetragraph Neuromuscular Transmission Monitor Ref K190795
Tetragraph Neuromuscular Transmission Monitor Ref K220530
TetraGraph Monitor Ref SEN 2015
TetraGraph Pole Clamp Kit Ref SEN 2101
TetraSens Pediatric Ref SEN 2009
TetraSensitive Ref SEN 2014
TetraSens Pediatric Ref SEN 2013
TetraSens Electrode Ref SEN 2012
TetraGraph Philips Interface Ref SEN 2007
TetraGraph Monitor Ref SEN 2001
EUDAMED certificates
Notified body 2797 1 certificate
- MDR 737446 Reissued
Quality management system EU MDR
- Issued
- 16 Sep 2026
- Expires
- 1 Dec 2031
- Valid from
- 2 Dec 2026
Related companies
Notified bodies
- Notified body 2797
FDA establishments
- Senzime Inc. Saint Louis, MO · US FEI 3016560306
Information
- Country
- Sweden
- Address
- 8, Verkstadsgatan , Uppsala, Sweden
- Website
- senzime.com
- [email protected]
- Phone
- +46705286330
- PRRC contact
- Johanna Faris
- EUDAMED SRN
- SE-MF-000016903
- FDA FEI number
- 3016490024