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C_ite Itc Tu 8
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 21049460Model CUSTOM
by Wsaud A/S
Identity
- Trade Name
- C_ITE ITC TU 8 EUDAMEDAudioService FDA UDI
- Generic Name
- Air-conduction hearing aid, in-the-ear FDA UDI
- Device Name
- C_ITE ITC TU 8 FDA UDI
- Model / Reference
- CUSTOM EUDAMED21049460 EUDAMEDITC tu 8 FDA UDI
- Description
- C_ITE ITC TU 8 FDA UDI
Identifiers
- Catalog Number
- 21049460 FDA UDI
- Primary DI / UDI-DI
- 05714880279894 EUDAMEDFDA UDI
- Basic UDI-DI
- 5714880-WSA-28-25-4U 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, in-the-ear 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
No
FDA UDI
Over-the-Counter
Yes
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 Itc Tu 8 by Wsaud A/S — 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 | 5714880-WSA-28-25-4U | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Wsaud A/S
- EUDAMED SRN
- DK-MF-000015974
Sources (2)
- EUDAMED 30abe7f0-bfa1-47d6-bf7a-2b5ec2ea50e8 61 fields · synced Jul 12, 2026
- FDA UDI f966b6b1-7cad-41f3-8f2f-2faef75d6058 35 fields · synced May 30, 2026