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Ha Magnify Mbb3d M33 Sred
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 21004316Model BTE
by Wsaud A/S
Identity
- Trade Name
- HA MAGNIFY MBB3D M33 SRED EUDAMEDWidex FDA UDI
- Generic Name
- Air-conduction hearing aid, behind-the-ear FDA UDI
- Device Name
- WIDEX MAGNIFY MBB3D 330 (Sporty Red) FDA UDI
- Model / Reference
- BTE EUDAMED21004316 EUDAMEDMBB3D 330 FDA UDI
- Description
- WIDEX MAGNIFY MBB3D 330 (Sporty Red) FDA UDI
Identifiers
- Catalog Number
- 21004316 FDA UDI
- Primary DI / UDI-DI
- 05706069947083 EUDAMEDFDA UDI
- Basic UDI-DI
- 5714880-WSA-72-10-47 EUDAMED
- FDA Product Code
- OSM FDA UDI
- EMDN Code
- Y2145060101 BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE) EUDAMED
- GMDN Term
- Air-conduction hearing aid, behind-the-ear 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 Mbb3d M33 Sred 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-72-10-47 | 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 cb3c3d3e-bb49-47f3-9503-2d494bd60375 61 fields · synced Jul 13, 2026
- FDA UDI 7293e6df-dc9f-4963-a8b7-192791bda3f5 35 fields · synced May 30, 2026