← Back to catalogue
Starkey Premium Custom Charger
EUDAMEDFDA UDIClass I (EU MDR)
Ref 43041Model Starkey Charger
Identity
- Trade Name
- Starkey Premium Custom Charger EUDAMEDSTARKEY FDA UDI
- Generic Name
- Noninvasive device battery charger FDA UDI
- Device Name
- Starkey Charger EUDAMED
- Model / Reference
- Starkey Charger EUDAMED43041 EUDAMEDSTARKEY CUSTOM CHARGER FDA UDI
Identifiers
- Catalog Number
- 43041-000, 43041-100, 43041-610 FDA UDI
- Primary DI / UDI-DI
- 00842318179722 EUDAMEDFDA UDI
- Basic UDI-DI
- 0842318143084UD EUDAMED
- Direct Marketing DI
- 00842318179722 EUDAMED
- FDA Product Code
- OSM FDA UDI
- EMDN Code
- Y214599 HEARING AIDS - OTHER EUDAMED
- GMDN Term
- Noninvasive device battery charger 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 Premium Custom Charger 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 | 0842318143084UD | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Starkey Laboratories Inc.
- EUDAMED SRN
- US-MF-000014382
- Authorised Representative
- Starkey Laboratories (Germany) GmbH DE-AR-000010831
Sources (2)
- EUDAMED 5ff31626-7efa-45e8-b8ad-7cb1109900a0 61 fields · synced Jun 17, 2026
- FDA UDI 3760d104-6884-46bb-a3cf-1ca73c49d4e7 34 fields · synced May 30, 2026