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Air Conduction Hearing Aid
EUDAMEDClass I (EU MDR)
Ref BL98UModel Audio Amplifier
Identity
- Device Name
- Air Conduction Hearing Aid EUDAMED
- Model / Reference
- Audio Amplifier EUDAMEDBL98U EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719962400013 EUDAMED
- Basic UDI-DI
- 47199624BL98UNB EUDAMED
- Direct Marketing DI
- 04719962400013 EUDAMED
- EMDN Code
- Y2145060101 BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Air-conduction hearing aid, behind-the-ear
Air Conduction Hearing Aid by Taiwan Diversitec Manufacturing Corp. — Class I — MDR — listed in EUDAMED — 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 (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 47199624BL98UNB | Class I | Active |
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Manufacturer
- Manufacturer
- Taiwan Diversitec Manufacturing Corp.
- EUDAMED SRN
- TW-MF-000048747
- Authorised Representative
- KOMAS Medical Technology GmbH DE-AR-000045617
Sources (1)
- EUDAMED d6bca837-243c-407a-b304-06b1081f1f28 61 fields · synced Jul 18, 2026