Identity
- Trade Name
- Philips FDA UDI
- Generic Name
- Air-conduction hearing aid, canal FDA UDI
- Device Name
- HL 7000, KIT IIC 10 85 BL HEARLINK 7000 FDA UDI
- Model / Reference
- 197691 FDA UDI
- Description
- HL 7000, KIT IIC 10 85 BL HEARLINK 7000 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05714464001880 FDA UDI
- FDA Product Code
- LRB FDA UDI
- GMDN Term
- Air-conduction hearing aid, canal 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
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, canal
Philips by Sbo Hearing A/S — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Air-conduction hearing aid, canal.
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- Oticon — Oticon A/S · Class II
- GN ReSound — Gn Hearing A/S · Class I
- MICROTECH — Starkey Laboratories Inc. · Class II
- Bernafon — Bernafon, Inc. · Class II
- KIND — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Sbo Hearing A/S
Sources (1)
- FDA UDI 8b909909-24de-4d6a-b69c-baa2dc7d1da8 34 fields · synced Jun 1, 2026