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Muse i ITC
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AHQCK1IModel Starkey Muse Custom
Identity
- Trade Name
- Muse i ITC EUDAMEDSTARKEY FDA UDI
- Generic Name
- Air-conduction hearing aid, canal FDA UDI
- Device Name
- Starkey Muse Custom EUDAMED
- Model / Reference
- Starkey Muse Custom EUDAMEDAHQCK1I EUDAMEDMUSE I2400 ITC FDA UDI
Identifiers
- Catalog Number
- CK1I FDA UDI
- Primary DI / UDI-DI
- 00842318109583 EUDAMEDFDA UDI
- Basic UDI-DI
- 08423181SATN1NFL EUDAMED
- Direct Marketing DI
- 00842318109583 EUDAMED
- FDA Product Code
- OSM FDA UDIKLW FDA UDI
- EMDN Code
- Y2145060202 HEARING AIDS IN-THE-CANAL (ITC) EUDAMED
- GMDN Term
- Air-conduction hearing aid, canal FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.3305 FDA UDI874.3400 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Muse i ITC by Starkey Laboratories Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08423181SATN1NFL | 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 de3115e3-348d-4ed4-9916-c6778a9aa3c2 61 fields · synced Jun 17, 2026
- FDA UDI ac1fbb1d-8a27-4709-9aaa-911c03fe51ae 34 fields · synced May 30, 2026