← Back to catalogue
Kit 5x5 Biomax 022 Mbt Hk 3 W/20
EUDAMEDClass IIa (EU MDR)
Ref 05.04.0891Model Orthodontic Brackets
Identity
- Trade Name
- KIT 5X5 BIOMAX 022 MBT HK 3 W/20 EUDAMED
- Model / Reference
- Orthodontic Brackets EUDAMED05.04.0891 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07899439216198 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
Kit 5x5 Biomax 022 Mbt Hk 3 W/20 by Aditek do Brasil SA — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 (1)
- EUDAMED 3ca94535-bd09-4cc1-88ff-8a99a88eff40 61 fields · synced Jul 19, 2026