Identity
- Trade Name
- Oticon FDA UDI
- Generic Name
- Air-conduction hearing aid, receiver-in-the-ear FDA UDI
- Device Name
- H11V2, DESIGNRITE 10 WL SOR FDA UDI
- Model / Reference
- 151310 FDA UDI
- Description
- H11V2, DESIGNRITE 10 WL SOR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05707131288769 FDA UDI
- FDA Product Code
- OSM FDA UDI
- GMDN Term
- Air-conduction hearing aid, receiver-in-the-ear 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
MR Unsafe FDA UDI
Category: Air-conduction hearing aid, receiver-in-the-ear
Oticon by Oticon A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Air-conduction hearing aid, receiver-in-the-ear.
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- EarQ — Sbo Hearing A/S · Class II
- Philips — Sbo Hearing A/S · Class II
- Lucid® — HEARING LAB TECHNOLOGY, LLC · Class II
- Sonic — Sbo Hearing A/S · 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
- Oticon A/S
Sources (1)
- FDA UDI d0eea36d-c23e-461c-85b7-9ae2ef1dcc69 34 fields · synced Jun 6, 2026