Identity
- Trade Name
- Philips FDA UDI
- Generic Name
- Air-conduction hearing aid, in-the-ear FDA UDI
- Device Name
- HL 3000, KIT 312 NFM R BE HEARLINK 3000 FDA UDI
- Model / Reference
- 197761 FDA UDI
- Description
- HL 3000, KIT 312 NFM R BE HEARLINK 3000 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05714464002306 FDA UDI
- FDA Product Code
- OSM FDA UDI
- GMDN Term
- Air-conduction hearing aid, 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, in-the-ear
Philips by Sbo Hearing A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Air-conduction hearing aid, in-the-ear.
- Bernafon — Bernafon, Inc. · Class II
- AUDIBEL — Starkey Laboratories Inc. · Class II
- Unitron — Unitron Hearing · Class I
- AGX — Widex A/S · Class II
- Widex — Widex A/S · Class II
- Ceretone — AUDICON CORPORATION · Class I
- Bernafon — Bernafon, Inc. · Class II
- AUDIGY — Starkey Laboratories 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
- Sbo Hearing A/S
Sources (1)
- FDA UDI df2fd4d1-3bd0-4829-ab00-72ddc95cbd2c 34 fields · synced Jun 7, 2026