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U45r-X Exclusive Roth .020 C/5
EUDAMEDClass IIa (EU MDR)
Ref 41121-C2531Model ExclusiveRef 41121-C2131
Identity
- Trade Name
- U45R-X EXCLUSIVE ROTH .020 C/5 EUDAMEDU45R-X EXCLUSIVE ROTH .020 EUDAMED
- Device Name
- Orthodontic Monoblock Bracket Steel EUDAMED
- Model / Reference
- Exclusive EUDAMED41121-C2531 EUDAMED41121-C2131 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07908610045066 EUDAMED07908610044915 EUDAMED
- Basic UDI-DI
- B-07908610045066 EUDAMEDB-07908610044915 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
Category: Orthodontic tube
U45r-X Exclusive Roth .020 C/5 by Id-Logical Industria E Comercio Ltda — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic tube.
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- Master Series Bracket — American Orthodontics · Class IIa
- Metal Brackets — Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda · Class IIa
- V-Slot — ASTAR ORTHODONTICS INC. · Class IIa
- Metal bracket conventional — Bernhard Förster GmbH · Class IIa
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-07908610045066 | 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 (2)
- EUDAMED aaed3b44-f7c6-4ebd-bf94-d9813ffcfc2e 61 fields · synced Jul 13, 2026
- EUDAMED 0398e9ec-5fa0-4fb6-8589-a407685796bf 61 fields · synced May 18, 2026