Identity
- Trade Name
- GoCheck Audiometric Headphone Assembly FDA UDI
- Generic Name
- Tone audiometer FDA UDI
- Device Name
- Audiometric Headphone Final Assembly FDA UDI
- Model / Reference
- Sennheiser HD280 Pro FDA UDI
- Description
- Audiometric Headphone Final Assembly FDA UDI
Identifiers
- Primary DI / UDI-DI
- B43061000060 FDA UDI
- FDA Product Code
- ETT FDA UDI
- GMDN Term
- Tone audiometer FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.1100 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 Audiometric Headphone Assembly by Gobiquity, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Benson — MAICO Diagnostics GmbH · Class II
- Maico — MAICO Diagnostics GmbH · 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 I | Pending data |
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Manufacturer
- Manufacturer
- Gobiquity, Inc.
Sources (1)
- FDA UDI 7e9ccaa8-d97c-4718-991f-4754b1bd2074 33 fields · synced May 30, 2026