Identity
- Trade Name
- OKB OTC Hearing Aid - Bluetooth Earphones FDA UDI
- Generic Name
- Air-conduction hearing aid, in-the-ear FDA UDI
- Device Name
- (Authentic Accessory) Bluetooth Earphones for OKB OTC Hearing Aid GV-SA03.60 FDA UDI
- Model / Reference
- HT001 FDA UDI
- Description
- (Authentic Accessory) Bluetooth Earphones for OKB OTC Hearing Aid GV-SA03.60 FDA UDI
Identifiers
- Catalog Number
- 30-81-0300-0303 FDA UDI
- Primary DI / UDI-DI
- 00193169003507 FDA UDI
- FDA Product Code
- QUG FDA UDI
- GMDN Term
- Air-conduction hearing aid, in-the-ear FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3305 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Air-conduction hearing aid, in-the-ear
OKB OTC Hearing Aid - Bluetooth Earphones by Ok Biotech Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Air-conduction hearing aid, in-the-ear.
- Bernafon — Bernafon, Inc. · Class II
- AUDIBEL — Starkey Laboratories Inc. · Class II
- Unitron — Unitron Hearing · Class I
- AGX — Widex A/S · Class II
- Widex — Widex A/S · Class II
- Ceretone — AUDICON CORPORATION · Class I
- Bernafon — Bernafon, Inc. · Class II
- AUDIGY — Starkey Laboratories Inc. · 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
- Ok Biotech Co., Ltd.
Sources (1)
- FDA UDI 767c484a-f04b-4e3d-8f34-d1919ac6f8c5 35 fields · synced Jun 8, 2026