TetraSensitive

by Senzime AB Sweden EUDAMED

Ref SEN 2014, SEN 2016 EMDN Z12062899

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number7350012440213RJ Basic UDI-DI	Date17 Jan 2024Registered	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference: SEN 2014, SEN 2016

Primary DI / UDI-DI: 07350012440213, 07350012440251
Basic UDI-DI: 7350012440213RJ, 7350012440251RS
EMDN Code: Z12062899 Neuromuscular stimulation equipment - other

Device Class: Class I
Market of Registration: Sweden

Manufacturer details

EUDAMED SRN: SE-MF-000016903

Other devices from Senzime AB

TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017)

Class II
TetraGraph Xcom

Class I
ExSpiron Pediatric PadSets

Class I
TetraSens Electrode

Class I
TetraHub

Class I
ExSpiron Adult PadSets

Class I

See all devices from Senzime AB →

Properties & raw data

Show properties, registry sources and raw records

Other properties (13)

Sterile: No
Implantable: No
Reusable: No
Contains Latex: No
Reprocessed: No
CMR Substance: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Endocrine Disruptor: No
Administering Medicine: No
Measuring Function: No
Incorporates Medicinal Product: No

Sources (2)

EUDAMED 015891c6-1d27-4980-a15a-a107c8e2b394 61 fields · synced 22 Oct 2026
EUDAMED 07350012440251|7350012440251RS 61 fields · synced 18 May 2026