Ha Magnify MBB3D M11 Ccrn
by Wsaud a/S
Ref 21004294Model BTE
Active
CE MDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number5714880-WSA-72-10-47 05706069946864 | Date11 Apr 2024 | StatusActive |
| United States | GUDID listing GUDID | Number05706069946864 | Date27 Mar 2021 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Ha Magnify MBB3D M11 Ccrn EUDAMEDWidex GUDID
- Generic Name
- Air-conduction hearing aid, behind-the-ear
- Model / Ref / Catalog
- BTE, 21004294, MBB3D 110
- Primary DI / UDI-DI
- 05706069946864
- Basic UDI-DI
- 5714880-WSA-72-10-47
- FDA Product Code
- OSM
- EMDN Code
- Y2145060101 Behind-the-ear hearing aids with receiver in the device (bte)
- GMDN Term
- Air-conduction hearing aid, behind-the-ear
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 874.3305
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | BTE 21004294 | MBB3D 110 |
| Device Class | Class IIa | Class II |
Manufacturer details
- EUDAMED SRN
- DK-MF-000015974
Other devices from Wsaud a/S
Properties
Other properties (22)
- Sterile: No
- Single Use: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Lot / Batch Number: No
- Expiration Date: No
- Manufacturing Date: No