Muse BTE13
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- Muse BTE13 EUDAMEDSTARKEY FDA UDI
- Generic Name
- Air-conduction hearing aid, behind-the-ear FDA UDI
- Device Name
- Starkey Muse Standard BTE EUDAMED
- Model / Reference
- Starkey Muse Standard BTE EUDAMED64185 EUDAMEDMuse 2400 BTE 13 FDA UDI
Identifiers
- Catalog Number
- 64185-1 FDA UDI
- Primary DI / UDI-DI
- 00842318107077 EUDAMEDFDA UDI
- Basic UDI-DI
- 0842318164204UU EUDAMED
- Direct Marketing DI
- 00842318107077 EUDAMED
- FDA Product Code
- KLW FDA UDIESD 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 II FDA UDI
- Regulation Number
- 874.3400 FDA UDI874.3300 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
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
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Air-conduction hearing aid, behind-the-ear
Muse BTE13 by Starkey Laboratories Inc. — Class IIa — MDR, 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
- HHM — Oticon A/S · Class II
- Signia — WS Audiology USA, Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0842318164204UU | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Starkey Laboratories Inc.
- EUDAMED SRN
- US-MF-000014382
- Authorised Representative
- Starkey Laboratories (Germany) GmbH DE-AR-000010831
Sources (2)
- EUDAMED d0ee1ec0-cddc-45c9-bab0-f94242067abf 61 fields · synced Jun 18, 2026
- FDA UDI e7df5e3d-5324-418c-821c-c2795d26b108 34 fields · synced May 30, 2026