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C_ite Insio 1nx Ite
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 10986222Model CUSTOM
by Signia GmbH
Identity
- Trade Name
- C_ITE INSIO 1NX ITE EUDAMEDSIGNIA FDA UDI
- Generic Name
- Air-conduction hearing aid, in-the-ear FDA UDI
- Device Name
- C_ITE INSIO 1NX ITE FDA UDI
- Model / Reference
- CUSTOM EUDAMED10986222 EUDAMEDInsio 1Nx ITE FDA UDI
- Description
- C_ITE INSIO 1NX ITE FDA UDI
Identifiers
- Catalog Number
- 10986222 FDA UDI
- Primary DI / UDI-DI
- 04063006013357 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04063006013357 EUDAMED
- FDA Product Code
- OSM 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 II FDA UDI
- Regulation Number
- 874.3305 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
C_ite Insio 1nx Ite by Signia 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-04063006013357 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Signia GmbH
- EUDAMED SRN
- DE-MF-000017173
Sources (2)
- EUDAMED 40c184d9-6bf8-4f6e-8865-05d4e546e6f6 61 fields · synced Jul 17, 2026
- FDA UDI a8fbd128-8a92-4209-aced-02d0c2920be2 35 fields · synced May 30, 2026