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SAMBA 2 GO w/o manuals

FDA UDI

Class II (US FDA UDI)

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

Identity

Trade Name
SAMBA 2 GO w/o manuals FDA UDI
Generic Name
Hearing aid/implant system functionality-enhancing device FDA UDI
Device Name
Audio Processor Streaming Device FDA UDI
Model / Reference
53292 FDA UDI
Description
Audio Processor Streaming Device FDA UDI

Identifiers

Primary DI / UDI-DI
09008737532925 FDA UDI
FDA Product Code
PFO FDA UDI
MPV FDA UDI
GMDN Term
Hearing aid/implant system functionality-enhancing device 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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Hearing aid/implant system functionality-enhancing device

SAMBA 2 GO w/o manuals 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 Hearing aid/implant system functionality-enhancing device.

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 163dc2fb-bf76-46ff-9f1d-f512be017c6c 35 fields · synced May 30, 2026