Identity
- Trade Name
- SAMBA 2 Remote (iOS) FDA UDI
- Generic Name
- Audiometric/hearing device software FDA UDI
- Device Name
- Mobile Application Remote Control FDA UDI
- Model / Reference
- 52603 FDA UDI
- Description
- Mobile Application Remote Control FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09008737526030 FDA UDI
- FDA Product Code
- PFO FDA UDIMPV FDA UDI
- GMDN Term
- Audiometric/hearing device software 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
No
FDA UDI
Over-the-Counter
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Audiometric/hearing device software
SAMBA 2 Remote (iOS) 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 Audiometric/hearing device software.
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- Widex — Widex A/S · Class I
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- hearX — INTRICON CORPORATION · Class II
- Sonova Brand — Sonova AG · Class II
- Sonova Brand — Sonova AG · 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
Sources (1)
- FDA UDI f31e1fbe-5b48-41eb-b4b1-ce4159f6becb 34 fields · synced Jun 8, 2026