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SENSIMED Triggerfish® Antenna LEFT

FDA UDI

Class II (US FDA UDI)

by Sensimed AG

Identity

Trade Name
SENSIMED Triggerfish® Antenna LEFT 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 left eye FDA UDI
Model / Reference
AL.3 FDA UDI
Description
A single unit of SENSIMED Triggerfish® eye patch antenna for use around the left eye FDA UDI

Identifiers

Catalog Number
ST2001 FDA UDI
Primary DI / UDI-DI
07640153470089 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

SENSIMED Triggerfish® Antenna LEFT by Sensimed AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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 b68d9aff-ad0a-4203-868f-785598251182 37 fields · synced May 31, 2026