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SENSIMED Triggerfish® Recorder Sleeve
FDA UDIClass II (US FDA UDI)
by Sensimed AG
Identity
- Trade Name
- SENSIMED Triggerfish® Recorder Sleeve FDA UDI
- Generic Name
- Personal device holder, single-use FDA UDI
- Device Name
- A box of ten SENSIMED Triggerfish® Recorder Sleeve FDA UDI
- Model / Reference
- 004 FDA UDI
- Description
- A box of ten SENSIMED Triggerfish® Recorder Sleeve FDA UDI
Identifiers
- Catalog Number
- ST4001 FDA UDI
- Primary DI / UDI-DI
- 07640153470126 FDA UDI
- 510(k) Number
- DEN140017 FDA UDI
- FDA Product Code
- PLZ FDA UDI
- GMDN Term
- Personal device holder, 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Personal device holder, single-use
SENSIMED Triggerfish® Recorder Sleeve by Sensimed AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
DEN140017 also covers:
- SENSIMED Triggerfish® Antenna LEFT — Sensimed AG
- SENSIMED Triggerfish® Antenna LEFT — Sensimed AG
- SENSIMED Triggerfish® Antenna RIGHT — Sensimed AG
- SENSIMED Triggerfish® Antenna RIGHT — Sensimed AG
- SENSIMED Triggerfish® Data Cable — Sensimed AG
- SENSIMED Triggerfish® Recorder — Sensimed AG
- SENSIMED Triggerfish® Sensor FLAT — Sensimed AG
- SENSIMED Triggerfish® Sensor FLAT — Sensimed AG
- SENSIMED Triggerfish® Sensor MEDIUM — Sensimed AG
- SENSIMED Triggerfish® Sensor MEDIUM — Sensimed AG
- SENSIMED Triggerfish® Sensor SMF — Sensimed AG
- SENSIMED Triggerfish® Sensor STEEP — Sensimed AG
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sensimed AG
Sources (1)
- FDA UDI 989db244-b7f6-46fe-9fc8-ae5ced203b56 36 fields · synced Jun 8, 2026