Identity
- Trade Name
- Coselgi FDA UDI
- Generic Name
- Hearing aid/implant system remote control FDA UDI
- Device Name
- Coselgi RC-DEX (DEX silver) FDA UDI
- Model / Reference
- RC-DEX FDA UDI
- Description
- Coselgi RC-DEX (DEX silver) FDA UDI
Identifiers
- Catalog Number
- 8 911 0200 093 FDA UDI
- Primary DI / UDI-DI
- 05706069500431 FDA UDI
- FDA Product Code
- ESD FDA UDI
- GMDN Term
- Hearing aid/implant system remote control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.3300 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
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
Yes
FDA UDI
MR Conditional FDA UDI
Category: Hearing aid/implant system remote control
Coselgi by Widex A/S — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hearing aid/implant system remote control.
- Sonic — Sbo Hearing A/S · Class II
- Philips — Sbo Hearing A/S · Class II
- Phonak Brand — Sonova AG · Class I
- Bernafon — Bernafon, Inc. · Class II
- Bernafon — Sbo Hearing A/S · Class II
- Neutral — Sbo Hearing A/S · Class II
- Lehiso — Sbo Hearing A/S · Class II
- Bernafon — Bernafon, 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 I | Pending data |
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Manufacturer
- Manufacturer
- Widex A/S
Sources (1)
- FDA UDI 0f1c8fa0-a585-4163-8486-f4031131b184 35 fields · synced May 30, 2026