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S_ite Active Mini 1ix R Gnblk
EUDAMEDClass IIa (EU MDR)
Ref 21054370Model INSTANT FIT
by Wsaud A/S
Identity
- Trade Name
- S_ITE ACTIVE MINI 1IX R GNBLK EUDAMED
- Model / Reference
- INSTANT FIT EUDAMED21054370 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05714880295894 EUDAMED
- Basic UDI-DI
- 5714880-WSA-28-30-4J 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
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
S_ite Active Mini 1ix R Gnblk by Wsaud A/S — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 5714880-WSA-28-30-4J | Class IIa | Active |
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Manufacturer
- Manufacturer
- Wsaud A/S
- EUDAMED SRN
- DK-MF-000015974
Sources (1)
- EUDAMED 8c20e150-9a3e-4324-b9b5-0c53634150ae 61 fields · synced Jun 19, 2026