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S_ite Xtm If Itc A4 R Bg
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 10943612Model INSTANT FIT
Identity
- Trade Name
- S_ITE XTM IF ITC A4 R BG EUDAMEDA&M FDA UDI
- Generic Name
- Air-conduction hearing aid, in-the-ear FDA UDI
- Device Name
- A&M S_ITE XTM IF A4 N-TAN R BG Hearing Aid FDA UDI
- Model / Reference
- INSTANT FIT EUDAMED10943612 EUDAMEDS_ITE XTM IF A4 N-TAN R BG FDA UDI
- Description
- A&M S_ITE XTM IF A4 N-TAN R BG Hearing Aid FDA UDI
Identifiers
- Catalog Number
- 10943612 FDA UDI
- Primary DI / UDI-DI
- 04056839013243 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04056839013243 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 Xtm If Itc A4 R 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-04056839013243 | 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 5080d699-747f-4168-844c-45d1bb8130b5 61 fields · synced Jul 11, 2026
- FDA UDI 5612f4dd-7311-4cc6-a17d-b1695b5c63e4 35 fields · synced May 29, 2026