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Ha Contrast Hp+ Dbr
EUDAMEDClass IIa (EU MDR)
Ref 10947518Model BTE
by Signia GmbH
Identity
- Trade Name
- HA CONTRAST HP+ DBR EUDAMED
- Model / Reference
- BTE EUDAMED10947518 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04056839034019 EUDAMED
- Basic UDI-DI
- B-04056839034019 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 Contrast Hp+ Dbr by Signia 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-04056839034019 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Signia GmbH
- EUDAMED SRN
- DE-MF-000017173
Sources (1)
- EUDAMED 6d1029be-27c3-4c47-96be-13d46473084e 61 fields · synced Jul 21, 2026