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SENSIMED Triggerfish® Antenna RIGHT

FDA UDI

Class II (US FDA UDI)

by Sensimed AG

Identity

Trade Name
SENSIMED Triggerfish® Antenna RIGHT FDA UDI
Generic Name
Ocular monitoring/recording system ambulatory antenna, single-use FDA UDI
Device Name
A single unit of SENSIMED Triggerfish® eye patch antenna for use around the right eye FDA UDI
Model / Reference
AR.3 FDA UDI
Description
A single unit of SENSIMED Triggerfish® eye patch antenna for use around the right eye FDA UDI

Identifiers

Catalog Number
ST2002 FDA UDI
Primary DI / UDI-DI
07640153470096 FDA UDI
510(k) Number
DEN140017 FDA UDI
FDA Product Code
PLZ FDA UDI
GMDN Term
Ocular monitoring/recording system ambulatory antenna, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
886.1925 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Ocular monitoring/recording system ambulatory antenna, single-use

The Sensimed Triggerfish Antenna RIGHT device is a single-use eye patch antenna for use around the right eye, designed to enable continuous wireless extraction of data from an implantable or nonimplantable ocular sensor. This external component is intended to be connected to the system monitor or reader and worn at close proximity to the eye, allowing for a constant link with the sensor. The device is single-use and has been tested and validated for its MR safety status.

Similar devices

Also classified as Ocular monitoring/recording system ambulatory antenna, single-use.

Cleared under the same submission

DEN140017 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sensimed AG

Sources (1)

  • FDA UDI 253ed63a-7da7-4c8a-94a3-d794f53142b4 37 fields · synced Jul 30, 2026