Identity
- Trade Name
- U2R KIRIONE ROTH .022 EUDAMED
- Device Name
- Orthodontic Monoblock Bracket Steel EUDAMED
- Model / Reference
- KiriOne EUDAMED41121-E2111 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07908610036149 EUDAMED
- Basic UDI-DI
- B-07908610036149 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
U2r Kirione Roth .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-07908610036149 | 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 6b1877ca-e67c-4ddd-9cbc-4612f3e40253 61 fields · synced Aug 4, 2026