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S_ite Ab Horizon 5x R Cic Blk Trd
EUDAMEDClass IIa (EU MDR)
Ref 10981017Model INSTANT FIT
Identity
- Trade Name
- S_ITE AB HORIZON 5X R CIC BLK TRD EUDAMED
- Model / Reference
- INSTANT FIT EUDAMED10981017 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04056839123461 EUDAMED
- Basic UDI-DI
- B-04056839123461 EUDAMED
- EMDN Code
- Y2145060201 HEARING AID IN THE-EAR (ITE) 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 Ab Horizon 5x R Cic Blk Trd by Sivantos 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-04056839123461 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sivantos GmbH
- EUDAMED SRN
- DE-MF-000014326
Sources (1)
- EUDAMED bd73d0ae-256f-4d8d-b2c2-4af892638746 61 fields · synced Jul 9, 2026