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100 Kits 5x5 Biomax 022 Roth Hk 3, 4, 5 Pack W/2000
EUDAMEDClass IIa (EU MDR)
Ref 05.04.0302SModel Orthodontic Brackets
Identity
- Trade Name
- 100 Kits 5x5 Biomax 022 Roth Hk 3,4,5 Pack W/2000 EUDAMED
- Model / Reference
- Orthodontic Brackets EUDAMED05.04.0302S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07899439282025 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
100 Kits 5x5 Biomax 022 Roth Hk 3, 4, 5 Pack W/2000 by Aditek do Brasil SA — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Orthodontic tube.
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- 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 |
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Manufacturer
- Manufacturer
- Aditek do Brasil SA
- EUDAMED SRN
- BR-MF-000018793
- Authorised Representative
- EC Certification Service GmbH AT-AR-000006658
Sources (1)
- EUDAMED b42b09ea-0028-4bd7-aa78-d40eec536fe9 61 fields · synced Jun 19, 2026