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Acc. Rc-Dex With Switch Dxblk
EUDAMEDFDA UDIClass I (EU MDR)
Ref 8 911 0300 092Model REMOTE
by Wsaud A/S
Identity
- Trade Name
- ACC. RC-DEX WITH SWITCH DXBLK EUDAMEDWidex FDA UDI
- Generic Name
- Hearing aid/implant system remote control FDA UDI
- Device Name
- Widex RC-DEX with switch (DEX black ) FDA UDI
- Model / Reference
- REMOTE EUDAMED8 911 0300 092 EUDAMEDRC-DEX FDA UDI
- Description
- Widex RC-DEX with switch (DEX black ) FDA UDI
Identifiers
- Catalog Number
- 8 911 0300 092 FDA UDI
- Primary DI / UDI-DI
- 05706069548686 EUDAMEDFDA UDI
- Basic UDI-DI
- 5714880-WSA-63-60-4W EUDAMED
- FDA Product Code
- ESD FDA UDI
- EMDN Code
- Y214580 HEARING AIDS OR HEARING DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Hearing aid/implant system remote control 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
MR Conditional FDA UDI
Acc. Rc-Dex With Switch Dxblk 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-63-60-4W | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Wsaud A/S
- EUDAMED SRN
- DK-MF-000015974
Sources (2)
- EUDAMED 68332240-3936-4719-ac74-7b93acc6636d 61 fields · synced Aug 1, 2026
- FDA UDI 3565ff6d-22ac-4e77-bfe8-feec3487793f 35 fields · synced May 29, 2026