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Kit 5x5 Biomax 022 Mbt Hk 3, 4, 5 W/20
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 05.04.0890Model Orthodontic Brackets
Identity
- Trade Name
- KIT 5X5 BIOMAX 022 MBT HK 3,4,5 W/20 EUDAMEDADITEK FDA UDI
- Generic Name
- Orthodontic bracket, metal FDA UDI
- Device Name
- Kit 5x5 BioMax 022 MBT Hk 3,4,5 w/20 FDA UDI
- Model / Reference
- Orthodontic Brackets EUDAMED05.04.0890 EUDAMEDFDA UDI
- Description
- Kit 5x5 BioMax 022 MBT Hk 3,4,5 w/20 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07899439210806 EUDAMEDFDA UDI
- Basic UDI-DI
- 7899439205J4 EUDAMED
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
- GMDN Term
- Orthodontic bracket, metal FDA UDI
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Kit 5x5 Biomax 022 Mbt Hk 3, 4, 5 W/20 by Aditek do Brasil SA — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7899439205J4 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 (2)
- EUDAMED 30d26401-068a-4803-b662-b7286b0cc14b 61 fields · synced Oct 6, 2026
- FDA UDI d384f6e6-c28f-4a3b-ab8b-c750e9607ec9 33 fields · synced May 30, 2026