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Baha

FDA UDI

Class II (US FDA UDI)

by Cochlear Bone Anchored Solutions AB

Identity

Trade Name
Baha FDA UDI
Generic Name
Hearing aid wireless-fitting computer-aided set FDA UDI
Device Name
Baha Fitting Software 4.0 FDA UDI
Model / Reference
94223 FDA UDI
Description
Baha Fitting Software 4.0 FDA UDI

Identifiers

Catalog Number
94223 FDA UDI
Primary DI / UDI-DI
09321502026383 FDA UDI
510(k) Number
K132278 FDA UDI
FDA Product Code
LXB FDA UDI
GMDN Term
Hearing aid wireless-fitting computer-aided set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.3302 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Hearing aid wireless-fitting computer-aided set

Baha by Cochlear Bone Anchored Solutions AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

K132278 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cochlear Bone Anchored Solutions AB

Sources (1)

  • FDA UDI c8acc9e5-9b2e-4575-93b9-81984c853224 36 fields · synced Jun 8, 2026