Identity
- Trade Name
- Senti Set 3 FDA UDI
- Generic Name
- Tone audiometer FDA UDI
- Device Name
- Senti Audiometry (Class 3 with HF) Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. Senti device with touchscreen AN100097 4. FW Labelprinter AN100414 5. Pure Tone Audiometer Class 3 AN100114 6. Pure Tone Audiometer High Frequency AN100454 7. Headphone HDA-300 AN100630 8. Bone conductor B-71 with Patient Response button AN100214 9. Power supply AN100083 10. USB data cable AN100089 FDA UDI
- Model / Reference
- 100460 FDA UDI
- Description
- Senti Audiometry (Class 3 with HF) Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. Senti device with touchscreen AN100097 4. FW Labelprinter AN100414 5. Pure Tone Audiometer Class 3 AN100114 6. Pure Tone Audiometer High Frequency AN100454 7. Headphone HDA-300 AN100630 8. Bone conductor B-71 with Patient Response button AN100214 9. Power supply AN100083 10. USB data cable AN100089 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260223142970 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
- Not 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
Senti Set 3 by PATH medical GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 70a40667-0b59-4e96-af47-24fcc185a2ea 34 fields · synced Jun 8, 2026