Identity
- Trade Name
- Senti Desktop Flex FDA UDI
- Generic Name
- Tone audiometer FDA UDI
- Device Name
- Senti Desktop Flex Screening 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 4 Advanced AN100653 7. Power supply AN100524 + AN100525-USA or AN101360 + 101251-USA optionally 8. USB data cable AN100418 FDA UDI
- Model / Reference
- 100470-SC FDA UDI
- Description
- Senti Desktop Flex Screening 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 4 Advanced AN100653 7. Power supply AN100524 + AN100525-USA or AN101360 + 101251-USA optionally 8. USB data cable AN100418 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260223145285 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 by PATH medical GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tone audiometer.
- TREMETRICS — MAICO Diagnostics GmbH · Class II
- SHOEBOX AUDIOMETRY — SHOEBOX Ltd · Class II
- 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 c9c57c57-9579-463d-9362-c6015f669544 33 fields · synced Jun 6, 2026