Identity
- Trade Name
- HA ADVANCE SP 317 DGT EUDAMED
- Model / Reference
- BTE EUDAMED10945757 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04056839014622 EUDAMED
- Basic UDI-DI
- B-04056839014622 EUDAMED
- EMDN Code
- Y2145060101 BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Ha Advance Sp 317 Dgt by Sivantos GmbH — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04056839014622 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sivantos GmbH
- EUDAMED SRN
- DE-MF-000014326
Sources (1)
- EUDAMED f941df80-0e08-4c49-943c-72152225579d 61 fields · synced Jul 10, 2026