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C_ite Insio 7nx Iic
EUDAMEDClass IIa (EU MDR)
Ref 10959601Model CUSTOM
by Signia GmbH
Identity
- Trade Name
- C_ITE INSIO 7NX IIC EUDAMED
- Model / Reference
- CUSTOM EUDAMED10959601 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04056839081341 EUDAMED
- Basic UDI-DI
- B-04056839081341 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
C_ite Insio 7nx Iic by Signia 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-04056839081341 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Signia GmbH
- EUDAMED SRN
- DE-MF-000017173
Sources (1)
- EUDAMED 28643977-dc08-4e2c-a664-fe2888cdfba7 61 fields · synced Jun 19, 2026