Mi2000 TICI UNICO FLEX24 SL T 5 mm Implant Kit
by MED-EL Elektromedizinische Geräte GmbH
Ref 49361Model UNICOKit
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number9008737PPUNICOKitWN 09008737493615 | Date3 Sep 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- UNICOKit, 49361
- Primary DI / UDI-DI
- 09008737493615
- Basic UDI-DI
- 9008737PPUNICOKitWN
- EMDN Code
- J0301 Cochlear implants
- Device Class
- Class III
- Medical Purpose
- MDR Art. 2(1): intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: — diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, and — diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability
Manufacturer details
- EUDAMED SRN
- AT-PR-000036933
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Properties
Other properties (1)
- Sterile: No