Identity
- Trade Name
- SAMBA 2 BB PoM, left FDA UDI
- Generic Name
- Bone-conduction hearing implant system sound processor/vibrator FDA UDI
- Device Name
- Audio Processor FDA UDI
- Model / Reference
- 52533 FDA UDI
- Description
- Audio Processor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09008737525330 FDA UDI
- FDA Product Code
- PFO FDA UDI
- GMDN Term
- Bone-conduction hearing implant system sound processor/vibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3340 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Bone-conduction hearing implant system sound processor/vibrator
SAMBA 2 BB PoM, left by Med-El Elektromedizinische Geräte Gesellschaft m.b.H. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone-conduction hearing implant system sound processor/vibrator.
- Baha 5 Power, Black — Cochlear Bone Anchored Solutions AB · Class II
- Baha 5 SuperPower Bodyworn cable — Cochlear Bone Anchored Solutions AB · Class II
- Baha — Cochlear Bone Anchored Solutions AB · Class II
- Cochlear Baha SoundBand unilateral, Dark Blue — Cochlear Bone Anchored Solutions AB · Class II
- Cochlear™ Baha® 6 Max Sound Processor, Silver — Cochlear Bone Anchored Solutions AB · Class II
- Abutment cover brown — Cochlear Bone Anchored Solutions AB · Class II
- Cochlear™ Baha® 6 Max Battery Door, Tamper Resistant — Cochlear Bone Anchored Solutions AB · Class II
- BP100 & Baha 4 Battery door Soft black — Cochlear Bone Anchored Solutions AB · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
Sources (1)
- FDA UDI fb3042ae-615c-4196-9983-f11df7be4a4a 35 fields · synced May 31, 2026