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Maico

FDA UDI

Class II (US FDA UDI)

by Sbo Hearing A/S

Identity

Trade Name
Maico FDA UDI
Generic Name
Hearing aid wireless-fitting computer-aided set FDA UDI
Device Name
INEO A 2 FW 1.0.0 FDA UDI
Model / Reference
246203 FDA UDI
Description
INEO A 2 FW 1.0.0 FDA UDI

Identifiers

Primary DI / UDI-DI
05714464060115 FDA UDI
FDA Product Code
KLW FDA UDI
OSM FDA UDI
GMDN Term
Hearing aid wireless-fitting computer-aided set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.3400 FDA UDI
874.3305 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

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Hearing aid wireless-fitting computer-aided set

Maico by Sbo Hearing A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hearing aid wireless-fitting computer-aided set.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sbo Hearing A/S

Sources (1)

  • FDA UDI b392fe4a-bf4d-4228-aa97-af6af096adf3 34 fields · synced May 30, 2026