Identity
- Trade Name
- Serenade Tinnitus Treatment System FDA UDI
- Generic Name
- Air-conduction tinnitus masker, in-the-ear FDA UDI
- Model / Reference
- 900000 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00861259000209 FDA UDI
- FDA Product Code
- KLW FDA UDI
- GMDN Term
- Air-conduction tinnitus masker, in-the-ear FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3400 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Air-conduction tinnitus masker, in-the-ear
Serenade Tinnitus Treatment System by Soundcure, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Air-conduction tinnitus masker, in-the-ear.
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- Tinnitus Masker — GENERAL HEARING INSTRUMENT, INC. · Class II
- Tinnitus Masker — GENERAL HEARING INSTRUMENT, INC. · Class II
- Simply Tranquil I — GENERAL HEARING INSTRUMENT, INC. · Class II
- Simply Tranquil I — GENERAL HEARING INSTRUMENT, INC. · Class II
- Simply Tranquil II — GENERAL HEARING INSTRUMENT, INC. · Class II
- Simply Tranquil II — GENERAL HEARING INSTRUMENT, INC. · Class II
- Tinnitus Masker — GENERAL HEARING INSTRUMENT, 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
- Soundcure, Inc.
Sources (1)
- FDA UDI d626e24a-c094-4e1b-b4e5-4143884172ad 33 fields · synced May 29, 2026