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U1r Kirione Clinic Line Roth .022 Pc C/50
EUDAMEDClass IIa (EU MDR)
Ref 41120-E2201Model KiriOne
Identity
- Trade Name
- U1R KIRIONE CLINIC LINE ROTH .022 PC C/50 EUDAMED
- Device Name
- Orthodontic Monoblock Bracket Steel EUDAMED
- Model / Reference
- KiriOne EUDAMED41120-E2201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07908610058271 EUDAMED
- Basic UDI-DI
- B-07908610058271 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
U1r Kirione Clinic Line Roth .022 Pc C/50 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-07908610058271 | 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 a53fd58d-ec3c-470b-8d61-6774ed2d3068 61 fields · synced Jul 11, 2026