Identity
- Trade Name
- Starkey Remote EUDAMEDSTARKEY HEARING TECHNOLOGIES FDA UDI
- Generic Name
- Hearing aid/implant system remote control FDA UDI
- Device Name
- Starkey Remote EUDAMED
- Model / Reference
- 43011 EUDAMEDSTARKEY HEARING TECHNOLOGIES REMOTE FDA UDI
Identifiers
- Catalog Number
- 43011-002 FDA UDI
- Primary DI / UDI-DI
- 00842318168450 EUDAMEDFDA UDI
- Basic UDI-DI
- 0842318143011TJ EUDAMED
- Direct Marketing DI
- 00842318168450 EUDAMED
- FDA Product Code
- OSM FDA UDI
- EMDN Code
- Y214599 HEARING AIDS - OTHER EUDAMED
- GMDN Term
- Hearing aid/implant system remote control FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 874.3305 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
Yes
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
Starkey Remote by Starkey Laboratories Inc. — Class I — 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 | 0842318143011TJ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 c7a6ae17-6ce9-4102-a4ef-fc1497667f3a 61 fields · synced Jul 17, 2026
- FDA UDI 815b0092-fb3c-44c3-882d-b7ce552f95dc 34 fields · synced May 30, 2026