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SENSIMED Triggerfish® Recorder

FDA UDI

Class II (US FDA UDI)

by Sensimed AG

Identity

Trade Name
SENSIMED Triggerfish® Recorder FDA UDI
Generic Name
Ocular volume ambulatory recording system recorder FDA UDI
Device Name
A small, battery operated electronic device that is used to operate the SENSIMED Triggerfish® Sensor and store the obtained data FDA UDI
Model / Reference
R.V.4.1 FDA UDI
Description
A small, battery operated electronic device that is used to operate the SENSIMED Triggerfish® Sensor and store the obtained data FDA UDI

Identifiers

Catalog Number
ST5000 FDA UDI
Primary DI / UDI-DI
07640153470133 FDA UDI
510(k) Number
DEN140017 FDA UDI
FDA Product Code
PLZ FDA UDI
GMDN Term
Ocular volume ambulatory recording system recorder 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

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Ocular volume ambulatory recording system recorder

SENSIMED Triggerfish® Recorder 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 57e90d2a-2442-47c8-b5e9-73314d213be7 37 fields · synced Jun 6, 2026