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spatial 4.0 Li
EUDAMEDClass IIa (EU MDR)
Ref 039943-B430-311-1720Model Hearing aid
Identity
- Trade Name
- spatial 4.0 Li EUDAMED
- Model / Reference
- Hearing aid EUDAMED039943-B430-311-1720 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +EADF039943B43031117201 EUDAMED
- Basic UDI-DI
- ++EADFa20HNPM EUDAMED
- EMDN Code
- Y2145060102 BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE CANAL (RIC, RITE) EUDAMED
Classification
- Device Class
- Class IIa 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
Category: Air-conduction hearing aid, receiver-in-canal
spatial 4.0 Li by audifon GmbH & Co. KG — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++EADFa20HNPM | Class IIa | Active |
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Manufacturer
- Manufacturer
- audifon GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000008355
Sources (1)
- EUDAMED 0e1ef8fc-def1-49a3-977a-81024a7e0a89 61 fields · synced Jun 18, 2026