Identity
- Trade Name
- JLAB FDA UDI
- Generic Name
- Air-conduction hearing aid, wearable case FDA UDI
- Model / Reference
- JLH-2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00198168321867 FDA UDI
- FDA Product Code
- QUF FDA UDI
- GMDN Term
- Air-conduction hearing aid, wearable case 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
No
FDA UDI
MR Unsafe FDA UDI
Jlab by JLab — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- JLab
Sources (1)
- FDA UDI 8c7d97f5-edb1-48f8-98cf-9c222f0f643c 33 fields · synced May 30, 2026