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Desyncra For Tinnitus Therapy System

FDA UDI

Class II (US FDA UDI)

by Desyncra Operating GmbH

Identity

Trade Name
Desyncra For Tinnitus Therapy System FDA UDI
Generic Name
Tinnitus masking application software FDA UDI
Model / Reference
Size XL FDA UDI

Identifiers

Catalog Number
TI10.04EU_01 FDA UDI
Primary DI / UDI-DI
EDYGTI1004EU01 FDA UDI
510(k) Number
K151558 FDA UDI
FDA Product Code
KLW FDA UDI
GMDN Term
Tinnitus masking application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.3400 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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Tinnitus masking application software

Desyncra For Tinnitus Therapy System by Desyncra Operating GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tinnitus masking application software.

Cleared under the same submission

K151558 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Desyncra Operating GmbH

Sources (1)

  • FDA UDI af04ca69-6f2d-408c-a765-5931769e7eba 34 fields · synced May 30, 2026