Identity
- Trade Name
- Baha Smart App FDA UDI
- Generic Name
- Audiometric/hearing device software FDA UDI
- Model / Reference
- P1646054 FDA UDI
Identifiers
- Catalog Number
- P1646054 FDA UDI
- Primary DI / UDI-DI
- 09321502052993 FDA UDI
- 510(k) Number
- K202048 FDA UDI
- FDA Product Code
- LXB FDA UDI
- GMDN Term
- Audiometric/hearing device software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3302 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Audiometric/hearing device software
Baha Smart App by Cochlear Bone Anchored Solutions AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Audiometric/hearing device software.
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- Sonova Brand — Sonova AG · Class II
Cleared under the same submission
K202048 also covers:
- Baha Smart App — Cochlear Bone Anchored Solutions AB
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- Cochlear™ Baha® 6 Max Demo Sound Processor, Black, 2mm — Cochlear Bone Anchored Solutions AB
- Cochlear™ Baha® 6 Max Sound Processor, Black — Cochlear Bone Anchored Solutions AB
- Cochlear™ Baha® 6 Max Sound Processor, Black, 2mm — Cochlear Bone Anchored Solutions AB
- Cochlear™ Baha® 6 Max Sound Processor, Blonde — Cochlear Bone Anchored Solutions AB
- Cochlear™ Baha® 6 Max Sound Processor, Blonde, 2mm — Cochlear Bone Anchored Solutions AB
- Cochlear™ Baha® 6 Max Sound Processor, Brown — Cochlear Bone Anchored Solutions AB
- Cochlear™ Baha® 6 Max Sound Processor, Brown, 2mm — Cochlear Bone Anchored Solutions AB
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
- Cochlear Bone Anchored Solutions AB
Sources (1)
- FDA UDI 92757b90-d0ef-4570-b742-575dd28b8a51 35 fields · synced Jun 8, 2026