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SilentCloud Web App 1.5.8

by Sonova AG

Ref 088-0037-00010Model Sonova tinnitus management system

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number07613389UTMST4 Basic UDI-DI 07613389938531UDI-DIDate29 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613389938531 UDI-DI Date24 Jun 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
SilentCloud Web App 1.5 EUDAMED
SilentCloud Web App GUDID
Generic Name
Tinnitus masking application software
Device Name
Sonova tinnitus management system
Model / Ref / Catalog
Sonova tinnitus management system, 088-0037-00010, 1.5.8
Primary DI / UDI-DI
07613389938531
Basic UDI-DI
07613389UTMST4
510(k) Number
FDA Product Code
KLW
EMDN Code
Z12040192 General medicine diagnosis and monitoring instruments - medical device software
GMDN Term
Tinnitus masking application software
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
874.3400
Special Device Type
Software
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Sonova tinnitus management system
088-0037-00010
GUDID
1.5.8
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K221125)

Other devices from Sonova AG

See all devices from Sonova AG →

Properties

  • Lot / Batch Number
  • Manufacturing Date

Other properties (22)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No