Identity
- Trade Name
- GoCheck FDA UDI
- Generic Name
- Tone audiometer FDA UDI
- Device Name
- Mobile Application for Hearing Screening FDA UDI
- Model / Reference
- Hearing Mobile App V1.0.0 FDA UDI
- Description
- Mobile Application for Hearing Screening FDA UDI
Identifiers
- Primary DI / UDI-DI
- B43056000011000 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
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Tone audiometer
GoCheck by Gobiquity, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Gobiquity, Inc.
Sources (1)
- FDA UDI efd5121e-4624-49ad-bd23-1aa719a338d6 33 fields · synced May 30, 2026