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AP Adapter

FDA UDI

Class III (US FDA UDI)

by Med-El Elektromedizinische Geräte Gesellschaft m.b.H.

Identity

Trade Name
AP Adapter FDA UDI
Generic Name
Partially-implantable middle ear implant system FDA UDI
Device Name
Audio Processor Adapter FDA UDI
Model / Reference
11334-001 FDA UDI
Description
Audio Processor Adapter FDA UDI

Identifiers

Primary DI / UDI-DI
09008738501463 FDA UDI
PMA Number
P990052 FDA UDI
FDA Product Code
MPV FDA UDI
GMDN Term
Partially-implantable middle ear implant system FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

Yes

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

No

FDA UDI

Category: Partially-implantable middle ear implant system

AP Adapter by Med-El Elektromedizinische Geräte Gesellschaft m.b.H. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Partially-implantable middle ear implant system.

Cleared under the same submission

P990052 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.

Sources (1)

  • FDA UDI ff4b6223-290b-4ffc-ba24-a577e1ac741b 36 fields · synced Jun 8, 2026