Ha Motion SA 5PX Spirit C5
by Signia GmbH
Ref 10934524Model BTE
Active
CE MDD
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/MDD EUDAMED | NumberB-04056839062920 04056839062920 | Date14 Jul 2025 | StatusActive |
| United States | GUDID listing GUDID | Number04056839062920 | Date2 May 2016 | 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- Withdrawn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 Motion SA 5PX Spirit C5 EUDAMEDSignia Siemens GUDID
- Generic Name
- Air-conduction hearing aid, behind-the-ear
- Model / Ref / Catalog
- BTE, 10934524, HA MOTION SA 5PX SPIRIT C5
- Primary DI / UDI-DI
- 04056839062920
- Basic UDI-DI
- B-04056839062920
- 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
- Not in Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | BTE 10934524 | HA MOTION SA 5PX SPIRIT C5 |
| Device Class | Class IIa | Class II |
Manufacturer details
- EUDAMED SRN
- DE-MF-000017173
Other devices from Signia GmbH
Properties
Other properties (21)
- 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
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Lot / Batch Number: No
- Expiration Date: No
- Manufacturing Date: No