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SENSIMED Triggerfish® Software

FDA UDI

Class II (US FDA UDI)

by Sensimed AG

Identity

Trade Name
SENSIMED Triggerfish® Software FDA UDI
Generic Name
Ocular volume ambulatory recording system software FDA UDI
Device Name
Computer software for the configuration of SENSIMED Triggerfish® monitoring session and subsequent downloading, display and analysis of data from these sessions FDA UDI
Model / Reference
V3 FDA UDI
Description
Computer software for the configuration of SENSIMED Triggerfish® monitoring session and subsequent downloading, display and analysis of data from these sessions FDA UDI

Identifiers

Catalog Number
ST8000 FDA UDI
Primary DI / UDI-DI
07640153470157 FDA UDI
510(k) Number
DEN140017 FDA UDI
FDA Product Code
PLZ FDA UDI
GMDN Term
Ocular volume ambulatory recording system software 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

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Ocular volume ambulatory recording system software

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

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 ab0eb009-0b09-457c-bc41-14773698ae2c 36 fields · synced Jun 1, 2026