Identity
- Trade Name
- Senti Desktop Flex (Basic Set) FDA UDI
- Generic Name
- Tone audiometer FDA UDI
- Device Name
- Senti Desktop Flex Basic Set Content: 1. Case AN100503 2. Inlay Sentiero AN100385 3. Senti Desktop Flex device AN100433 4. Headphone DD-45 AN100306 5. FW Labelprinter AN100414 6. FW Pure Tone Audiometer Class 3 AN100114 7. Bone Conductor B81 AN100888 or B71W AN100344 optionally 8. Patient response button AN100171 9. Power supply AN100524 + AN100525-USA or AN101360 + AN101251-USA optionally 10. USB data cable AN100418 FDA UDI
- Model / Reference
- 100470 FDA UDI
- Description
- Senti Desktop Flex Basic Set Content: 1. Case AN100503 2. Inlay Sentiero AN100385 3. Senti Desktop Flex device AN100433 4. Headphone DD-45 AN100306 5. FW Labelprinter AN100414 6. FW Pure Tone Audiometer Class 3 AN100114 7. Bone Conductor B81 AN100888 or B71W AN100344 optionally 8. Patient response button AN100171 9. Power supply AN100524 + AN100525-USA or AN101360 + AN101251-USA optionally 10. USB data cable AN100418 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260223142987 FDA UDI
- FDA Product Code
- EWO FDA UDI
- GMDN Term
- Tone audiometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.1050 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Tone audiometer
Senti Desktop Flex (Basic Set) by PATH medical GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tone audiometer.
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- Otometrics — Natus Medical Denmark ApS · Class II
- TRIANGLE — INVENTIS SRL · Class II
- Benson — MAICO Diagnostics GmbH · Class II
- Maico — MAICO Diagnostics GmbH · Class II
- VIOLA — INVENTIS SRL · Class II
- VIOLA — INVENTIS SRL · Class II
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 |
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Manufacturer
- Manufacturer
- PATH medical GmbH
Sources (1)
- FDA UDI 0bf3960f-f47f-43af-8026-95d86c679eee 33 fields · synced May 30, 2026