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S_ite Inox Itc 10 L Bg
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 10943519Model INSTANT FIT
Identity
- Trade Name
- S_ITE INOX ITC 10 L BG EUDAMEDRexton FDA UDI
- Generic Name
- Air-conduction hearing aid, in-the-ear FDA UDI
- Device Name
- Rexton S_ITE INOX 10 N-TAN L BG Hearing Aid FDA UDI
- Model / Reference
- INSTANT FIT EUDAMED10943519 EUDAMEDS_ITE INOX 10 N-TAN L BG FDA UDI
- Description
- Rexton S_ITE INOX 10 N-TAN L BG Hearing Aid FDA UDI
Identifiers
- Catalog Number
- 10943519 FDA UDI
- Primary DI / UDI-DI
- 04056839007235 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04056839007235 EUDAMED
- FDA Product Code
- ESD FDA UDI
- EMDN Code
- Y2145060201 HEARING AID IN THE-EAR (ITE) EUDAMED
- GMDN Term
- Air-conduction hearing aid, in-the-ear FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 874.3300 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
S_ite Inox Itc 10 L Bg by Sivantos GmbH — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04056839007235 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Sivantos GmbH
- EUDAMED SRN
- DE-MF-000014326
Sources (2)
- EUDAMED 5b971d59-597a-4c2f-a8df-039bb3b2cd9b 61 fields · synced Jun 18, 2026
- FDA UDI cdfa6867-09a7-4758-8524-f7dcbf914762 35 fields · synced May 25, 2026