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U45r-X Kirione Orto Intelligence .022
EUDAMEDClass IIa (EU MDR)
Ref 411D1-E2131Model KiriOne
Identity
- Trade Name
- U45R-X KIRIONE ORTO INTELLIGENCE .022 EUDAMED
- Device Name
- Orthodontic Monoblock Bracket Steel EUDAMED
- Model / Reference
- KiriOne EUDAMED411D1-E2131 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07908610051685 EUDAMED
- Basic UDI-DI
- B-07908610051685 EUDAMED
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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
U45r-X Kirione Orto Intelligence .022 by Id-Logical Industria E Comercio Ltda — 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-07908610051685 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Id-Logical Industria E Comercio Ltda
- EUDAMED SRN
- BR-MF-000034402
- Authorised Representative
- EC Certification Service GmbH AT-AR-000006658
Sources (1)
- EUDAMED 755bf84b-f849-449f-a8a9-756a7ea77b62 61 fields · synced Jul 19, 2026