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S_ite M-Core Cros Ix-Cic Moc Trd
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 10990816Model INSTANT FIT
Identity
- Trade Name
- S_ITE M-CORE CROS IX-CIC MOC TRD EUDAMEDRexton FDA UDI
- Generic Name
- Contralateral hearing unit FDA UDI
- Device Name
- M-Core CROS IX-CIC Mocha Red FDA UDI
- Model / Reference
- INSTANT FIT EUDAMED10990816 EUDAMEDM-Core CROS IX-CIC FDA UDI
- Description
- M-Core CROS IX-CIC Mocha Red FDA UDI
Identifiers
- Catalog Number
- 10990816 FDA UDI
- Primary DI / UDI-DI
- 04056839134337 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04056839134337 EUDAMED
- FDA Product Code
- OSM FDA UDIKLW FDA UDI
- EMDN Code
- Y2145060201 HEARING AID IN THE-EAR (ITE) EUDAMED
- GMDN Term
- Contralateral hearing unit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.3305 FDA UDI874.3400 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 M-Core Cros Ix-Cic Moc Trd 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-04056839134337 | 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 a0165348-9dc8-4bcf-8dd5-2c10478f4941 61 fields · synced Jul 13, 2026
- FDA UDI fc8e6ed5-4a69-45b1-941c-ebd81a0f16d6 35 fields · synced May 22, 2026