Identity
- Trade Name
- HA VOLTA P T DBR EUDAMEDAudio Service FDA UDI
- Generic Name
- Air-conduction hearing aid, behind-the-ear FDA UDI
- Device Name
- Audio Service HA VOLTA P T DBR Hearing Aid FDA UDI
- Model / Reference
- BTE EUDAMED10940410 EUDAMEDHA VOLTA P T DBR FDA UDI
- Description
- Audio Service HA VOLTA P T DBR Hearing Aid FDA UDI
Identifiers
- Catalog Number
- 10940410 FDA UDI
- Primary DI / UDI-DI
- 04056839002933 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04056839002933 EUDAMED
- FDA Product Code
- ESD FDA UDI
- EMDN Code
- Y2145060101 BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE) EUDAMED
- GMDN Term
- Air-conduction hearing aid, behind-the-ear FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 874.3300 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Ha Volta P T Dbr by AS AUDIO-SERVICE GmbH — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04056839002933 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- AS AUDIO-SERVICE GmbH
- EUDAMED SRN
- DE-MF-000012295
Sources (2)
- EUDAMED f29be8e2-194a-4e80-89dc-b69fe80b9f64 61 fields · synced Jul 19, 2026
- FDA UDI 1ac5b5f0-d24f-49be-8d8d-a0d3f12fffa1 36 fields · synced May 30, 2026