← Back to catalogue
TV-Controller II DEX (DEX silver )
EUDAMEDFDA UDIClass I (EU MDR)
Ref 8 912 0700 093Model STREAMER
by Wsaud A/S
Identity
- Trade Name
- TV-Controller II DEX (DEX silver ) EUDAMEDWidex FDA UDI
- Generic Name
- Hearing aid enhanced audio device, telecommunication/multimedia FDA UDI
- Device Name
- TV-Controller II DEX (DEX silver ) FDA UDI
- Model / Reference
- STREAMER EUDAMED8 912 0700 093 EUDAMEDTV-Controller II FDA UDI
- Description
- TV-Controller II DEX (DEX silver ) FDA UDI
Identifiers
- Catalog Number
- 8 912 0700 093 FDA UDI
- Primary DI / UDI-DI
- 05706069656473 EUDAMEDFDA UDI
- Basic UDI-DI
- 5714880-WSA-63-54-55 EUDAMED
- FDA Product Code
- ESD FDA UDI
- EMDN Code
- Y214580 HEARING AIDS OR HEARING DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Hearing aid enhanced audio device, telecommunication/multimedia FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 874.3300 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
TV-Controller II DEX (DEX silver ) by Wsaud A/S — 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 | 5714880-WSA-63-54-55 | 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
- Wsaud A/S
- EUDAMED SRN
- DK-MF-000015974
Sources (2)
- EUDAMED 26464e15-57a0-4ffa-8143-f5855b4e13e8 61 fields · synced Jun 19, 2026
- FDA UDI 11eed510-18b3-4349-8cb3-3fd2bd43aa98 35 fields · synced May 30, 2026