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Ha Demo Volta Hp M Bg

by AS AUDIO-SERVICE GmbH

Ref 10958782Model BTE

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04038953878212 Basic UDI-DI 04038953878212UDI-DIDate15 Jul 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04038953878212 UDI-DI Date17 Apr 2019ListedStatusListed GUDID: not 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.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Ha Demo Volta Hp M Bg EUDAMED
Audio Service GUDID
Generic Name
Air-conduction hearing aid, behind-the-ear
Model / Ref / Catalog
BTE, 10958782, HA DEMO VOLTA HP M BG
Primary DI / UDI-DI
04038953878212
Basic UDI-DI
B-04038953878212
FDA Product Code
ESD
EMDN Code
Y2145060101 Behind-the-ear hearing aids with receiver in the device (bte)
GMDN Term
Air-conduction hearing aid, behind-the-ear
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
874.3300
EU market of registration
Germany
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
BTE
10958782
GUDID
HA DEMO VOLTA HP M BG
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
DE-MF-000012295

Related devices

Category: Air-conduction hearing aid, behind-the-ear

Other devices from AS AUDIO-SERVICE GmbH

See all devices from AS AUDIO-SERVICE GmbH →

Properties

  • Prescription Use
  • Premarket Exempt
  • Serial Number

Other properties (21)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No