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Audibel Signature Series 16 Iic Nw
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref P00004193
Identity
- Trade Name
- AUDIBEL SIGNATURE SERIES 16 IIC NW EUDAMEDAUDIBEL FDA UDI
- Generic Name
- Air-conduction hearing aid, canal FDA UDI
- Device Name
- Signature Series Custom EUDAMED
- Model / Reference
- P00004193 EUDAMEDAUDIBEL SIGNATURE SERIES 16 IIC NW FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840388202012 EUDAMEDFDA UDI
- Basic UDI-DI
- 08423181P000044 EUDAMED
- FDA Product Code
- ESD FDA UDIKLW FDA UDI
- EMDN Code
- Y2145060203 HEARING AIDS COMPLETELY-IN-THE-CANAL (CIC) EUDAMED
- GMDN Term
- Air-conduction hearing aid, canal FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 874.3300 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
Audibel Signature Series 16 Iic Nw 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 | 08423181P000044 | 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 e7bfedf1-2919-433e-80ff-bd06879c2e9d 61 fields · synced Oct 6, 2026
- FDA UDI 76327b1c-7520-4013-a0c8-8d829a35c332 33 fields · synced May 30, 2026