Identity
- Trade Name
- HA INSYNC R S8 SLV EUDAMED
- Model / Reference
- RIC EUDAMED11000841 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04038953890511 EUDAMED
- Basic UDI-DI
- B-04038953890511 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
Category: Air-conduction hearing aid, receiver-in-canal
Ha Insync R S8 Slv by AS AUDIO-SERVICE GmbH — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-04038953890511 | Class IIa | Active |
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Manufacturer
- Manufacturer
- AS AUDIO-SERVICE GmbH
- EUDAMED SRN
- DE-MF-000012295
Sources (1)
- EUDAMED e8b7c13c-aaf5-4b68-8a8c-1668619aaf25 61 fields · synced Jul 16, 2026