Identity
- Trade Name
- AP Fitting Kit Amadé FDA UDI
- Generic Name
- Partially-implantable middle ear implant system sound processor FDA UDI
- Device Name
- Audio Processor Fitting Kit FDA UDI
- Model / Reference
- 51068 FDA UDI
- Description
- Audio Processor Fitting Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09008738510687 FDA UDI
- PMA Number
- P990052 FDA UDI
- FDA Product Code
- MPV FDA UDI
- GMDN Term
- Partially-implantable middle ear implant system sound processor FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- Not 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
Yes
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
No
FDA UDI
AP Fitting Kit Amadé by Med-El Elektromedizinische Geräte Gesellschaft m.b.H. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
P990052 also covers:
- AP Adapter — Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
- Remote Control — Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
- SAMBA 2 Hi AP unit, left — Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
- SAMBA 2 Hi AP unit, right — Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
- SAMBA 2 Hi PoM, left — Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
- SAMBA 2 Hi PoM, right — Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
- SAMBA 2 Hi User Kit, Left — Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
- SAMBA 2 Hi User Kit, Right — Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
- SAMBA 2 Lo AP unit, left — Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
- SAMBA 2 Lo AP unit, right — Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
- SAMBA 2 Lo PoM, left — Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
- SAMBA 2 Lo PoM, right — Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
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 III | Pending data |
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Manufacturer
Sources (1)
- FDA UDI 2cb920cd-679a-43ca-b723-82544c6e7413 36 fields · synced Jun 1, 2026