Identity
- Trade Name
- Go Prime FDA UDI
- Generic Name
- Air-conduction hearing aid, in-the-ear FDA UDI
- Device Name
- Go Prime - Black - WAG Online FDA UDI
- Model / Reference
- Go Hearing FDA UDI
- Description
- Go Prime - Black - WAG Online FDA UDI
Identifiers
- Catalog Number
- GHPS00003BL FDA UDI
- Primary DI / UDI-DI
- 00810153660040 FDA UDI
- FDA Product Code
- QUF FDA UDI
- GMDN Term
- Air-conduction hearing aid, in-the-ear FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.3300 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
No
FDA UDI
Over-the-Counter
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Go Prime by Hearx Group (pty) Ltd — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Hearx Group (pty) Ltd
Sources (1)
- FDA UDI 9f7761d5-a127-4443-9d12-f50980e98507 36 fields · synced Jun 8, 2026