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Ha Magnify Mrr2d M10 Tcblk
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 21004452Model RICRef 21004530
by Wsaud A/S
Identity
- Trade Name
- HA MAGNIFY MRR2D M10 TCBLK EUDAMEDHA MAGNIFY MRB2D M10 TCBLK EUDAMEDWidex FDA UDI
- Generic Name
- Air-conduction hearing aid, receiver-in-canal FDA UDI
- Device Name
- WIDEX MAGNIFY MRB2D 100 (Tech Black) FDA UDIWIDEX MAGNIFY MRR2D 100 (Tech Black) FDA UDI
- Model / Reference
- RIC EUDAMED21004452 EUDAMED21004530 EUDAMEDMRB2D 100 FDA UDIMRR2D 100 FDA UDI
- Description
- WIDEX MAGNIFY MRB2D 100 (Tech Black) FDA UDIWIDEX MAGNIFY MRR2D 100 (Tech Black) FDA UDI
Identifiers
- Catalog Number
- 21004530 FDA UDI21004452 FDA UDI
- Primary DI / UDI-DI
- 05706069949483 EUDAMEDFDA UDI05706069951431 EUDAMEDFDA UDI
- Basic UDI-DI
- 5714880-WSA-72-15-4N EUDAMED
- FDA Product Code
- OSM FDA UDI
- EMDN Code
- Y2145060102 BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE CANAL (RIC, RITE) EUDAMED
- GMDN Term
- Air-conduction hearing aid, receiver-in-canal FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.3305 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
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
Ha Magnify Mrr2d M10 Tcblk 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-72-15-4N | 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 (4)
- EUDAMED eabd0f1d-5059-4678-818e-07d1f179ffa4 61 fields · synced Jul 29, 2026
- FDA UDI eb79d34d-d151-4c16-89da-8a6a5eee8278 35 fields · synced May 30, 2026
- FDA UDI 1c7d4ba5-a43f-4fb1-8f35-9cef77bb2334 35 fields · synced May 30, 2026
- EUDAMED 38707804-71f4-4708-9e9f-062505f846f1 61 fields · synced Jul 29, 2026