Identity
- Trade Name
- HA P 4 G4 DGT EUDAMEDAudio Service FDA UDI
- Generic Name
- Air-conduction hearing aid, behind-the-ear FDA UDI
- Device Name
- Audio Service HA P 4 G4 DGT Hearing Aid FDA UDI
- Model / Reference
- BTE EUDAMED10950561 EUDAMEDHA P 4 G4 DGT FDA UDI
- Description
- Audio Service HA P 4 G4 DGT Hearing Aid FDA UDI
Identifiers
- Catalog Number
- 10950561 FDA UDI
- Primary DI / UDI-DI
- 04038953868862 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04038953868862 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
Category: Air-conduction hearing aid, behind-the-ear
Ha P 4 G4 Dgt by AS AUDIO-SERVICE GmbH — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Air-conduction hearing aid, behind-the-ear.
- Oticon — Oticon A/S · Class II
- Amplifon — Sonova AG · Class II
- Phonak Naída L30-SP — Sonova AG · Class II
- Phonak — Phonak, Inc. · Class II
- GN ReSound — Gn Hearing A/S · Class II
- Miracle-Ear — WS Audiology USA, Inc. · Class II
- NUEAR — Starkey Laboratories Inc. · Class II
- HHM — Oticon A/S · Class II
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-04038953868862 | 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 f44bef00-2cae-4183-bf07-9f7c049c7d1f 61 fields · synced Jun 19, 2026
- FDA UDI 1118034d-87c4-4c8c-abd6-e1be9b1bb69b 36 fields · synced May 30, 2026