← Back to catalogue
Bracket Easyclip+ Passive 018 Roth Ul3 Hk 0°t 11°a 4°o W/10
EUDAMEDClass IIa (EU MDR)
Ref 05.20.0323TModel Orthodontic BracketsRef 05.20.0323O
Identity
- Trade Name
- BRACKET EASYCLIP+ PASSIVE 018 ROTH UL3 HK 0°T 11°A 4°O W/10 EUDAMEDBRACKET EASYCLIP+ PASSIVE 018 ROTH UL3 HK 0°T 11°A 4°O W/1 EUDAMED
- Model / Reference
- Orthodontic Brackets EUDAMED05.20.0323T EUDAMED05.20.0323O EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07899439285521 EUDAMED07899439295452 EUDAMED
- Basic UDI-DI
- 7899439205J4 EUDAMED
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
Bracket Easyclip+ Passive 018 Roth Ul3 Hk 0°t 11°a 4°o W/10 by Aditek do Brasil SA — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic tube.
- Master Series Bracket — American Orthodontics · Class IIa
- Metal brackets conventional milled — Bernhard Förster GmbH · Class IIa
- Ceramic brackets conventional — Bernhard Förster GmbH · Class IIa
- Metal bracket conventional — Bernhard Förster GmbH · Class IIa
- Master Series Bracket — American Orthodontics · Class IIa
- CASO KIRIONE ROTH .022 7X7 (3-4-5) C/10 — ID-LOGICAL INDUSTRIA E COMERCIO LTDA · Class IIa
- Metal Brackets — Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda · Class IIa
- V-Slot — ASTAR ORTHODONTICS INC. · Class IIa
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7899439205J4 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Aditek do Brasil SA
- EUDAMED SRN
- BR-MF-000018793
- Authorised Representative
- EC Certification Service GmbH AT-AR-000006658
Sources (2)
- EUDAMED 661bfcae-5e89-4a51-b6b6-4fca766100ad 61 fields · synced Oct 6, 2026
- EUDAMED ee129c7e-caed-4ee9-ac49-514f761514cc 61 fields · synced May 17, 2026