Identity
- Trade Name
- C_ITE SINA 3 G4 EUDAMEDAudio Service FDA UDI
- Generic Name
- Air-conduction hearing aid, in-the-ear FDA UDI
- Device Name
- Audio Service C_ITE SINA 3 G4 Hearing Aid FDA UDI
- Model / Reference
- CUSTOM EUDAMED10953361 EUDAMEDC_ITE SINA 3 G4 FDA UDI
- Description
- Audio Service C_ITE SINA 3 G4 Hearing Aid FDA UDI
Identifiers
- Catalog Number
- 10953361 FDA UDI
- Primary DI / UDI-DI
- 04038953870858 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04038953870858 EUDAMED
- FDA Product Code
- ESD FDA UDI
- EMDN Code
- Y2145060201 HEARING AID IN THE-EAR (ITE) EUDAMED
- GMDN Term
- Air-conduction hearing aid, in-the-ear FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 874.3300 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- Not 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
No
FDA UDI
C_ite Sina 3 G4 by AS AUDIO-SERVICE GmbH — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04038953870858 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- AS AUDIO-SERVICE GmbH
- EUDAMED SRN
- DE-MF-000012295
Sources (2)
- EUDAMED f839f6b1-7ff9-4f6b-9ab8-87115bb39dd4 61 fields · synced Oct 6, 2026
- FDA UDI 8c993f9b-7ac4-46cd-891a-7d6128e966d1 36 fields · synced May 30, 2026