Identity
- Trade Name
- HA INSYNC S1 SB EUDAMED
- Model / Reference
- RIC EUDAMED11000787 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04038953890474 EUDAMED
- Basic UDI-DI
- B-04038953890474 EUDAMED
- EMDN Code
- Y2145060102 BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE CANAL (RIC, RITE) 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 Insync S1 Sb by AS AUDIO-SERVICE 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-04038953890474 | Class IIa | Active |
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Manufacturer
- Manufacturer
- AS AUDIO-SERVICE GmbH
- EUDAMED SRN
- DE-MF-000012295
Sources (1)
- EUDAMED 49ed8bbc-9b08-4427-9912-d723fad41f09 61 fields · synced Jun 18, 2026