Identity
- Trade Name
- SIGNIA FDA UDI
- Generic Name
- Audiometric/hearing device software FDA UDI
- Device Name
- SOFTWARE CONNEXX 9.8 FDA UDI
- Model / Reference
- Connexx 9.8 FDA UDI
- Description
- SOFTWARE CONNEXX 9.8 FDA UDI
Identifiers
- Catalog Number
- 21016993 FDA UDI
- Primary DI / UDI-DI
- 05714880169393 FDA UDI
- FDA Product Code
- OSM FDA UDI
- GMDN Term
- Audiometric/hearing device software 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
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Audiometric/hearing device software
Signia by WS Audiology USA, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Audiometric/hearing device software.
- CUSTOM SND SUITE 1.3 SERV RELEASE 1 — Cochlear · Class III
- Boots Hearingcare 2 — Sonova AG · Class II
- Sonova Brand — Sonova AG · Class II
- Widex — Widex A/S · Class I
- Nucleus — Cochlear · Class III
- hearX — INTRICON CORPORATION · Class II
- Sonova Brand — Sonova AG · Class II
- Sonova Brand — Sonova AG · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- WS Audiology USA, Inc.
Sources (1)
- FDA UDI aad5246e-89b9-4751-8e74-2ed69e27b5e8 35 fields · synced May 30, 2026