Identity
- Trade Name
- rega CIC EUDAMED
- Model / Reference
- Hearing aid EUDAMED023305-9112-315-357 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-023305-9112-315-357B4 EUDAMED
- Basic UDI-DI
- B-023305-9112-315-357B4 EUDAMED
- EMDN Code
- Y2145060203 HEARING AIDS COMPLETELY-IN-THE-CANAL (CIC) 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
rega CIC by audifon GmbH & Co. KG — 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-023305-9112-315-357B4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- audifon GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000008355
Sources (1)
- EUDAMED 5055c045-44a5-494c-ae4c-fca22a2bafe1 61 fields · synced Jun 18, 2026