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TetraSens SEN 2012 TetraSens

by Senzime AB (Publ.)

TetraSens SEN 2012 TetraSens is a Class II device made by Senzime AB (Publ.), listed in FDA GUDID since 26 Apr 2024 (UDI-DI 07350012440169), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07350012440169 UDI-DI Date26 Apr 2024ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
TetraSens
Generic name
Block-monitoring peripheral nerve electrical stimulation system
Model / Ref / Catalog
SEN 2012 TetraSens, SEN 2012
Primary DI / UDI-DI
07350012440169
FDA product code
KOI
GMDN term
Block-monitoring peripheral nerve electrical stimulation system
Device class
Class II
Regulation number
868.2775
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Block-monitoring peripheral nerve electrical stimulation system

Similar devices

Other devices filed under FDA product code KOI (Stimulator, Nerve, Peripheral, Electric).

Other devices from Senzime AB (Publ.)

See all devices from Senzime AB (Publ.) →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)