Identity
- Trade Name
- Soundwave Hearing FDA UDI
- Generic Name
- Earmould, preformed FDA UDI
- Device Name
- CLOSED-LARGE/991016-SWH; 10-pc blister pack of replacement ear domes for RIC used on Sontro Self-Fitting OTC Hearing Aids FDA UDI
- Model / Reference
- 991016-SWH FDA UDI
- Description
- CLOSED-LARGE/991016-SWH; 10-pc blister pack of replacement ear domes for RIC used on Sontro Self-Fitting OTC Hearing Aids FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850016231345 FDA UDI
- FDA Product Code
- QUH FDA UDI
- GMDN Term
- Earmould, preformed FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3325 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Earmould, preformed
Soundwave Hearing by Soundwave Hearing, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Earmould, preformed.
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- GN Hearing — Gn Hearing A/S · Class II
- GN Hearing — Gn Hearing A/S · Class II
- GN Hearing — Gn Hearing A/S · Class II
- Cochlear™ Hybrid™ Bass Double Dome, 10 mm — Cochlear · Class III
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
- Soundwave Hearing, Llc
Sources (1)
- FDA UDI 351765f2-8b2c-4c1a-b213-f87ad259b352 34 fields · synced May 31, 2026