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100 Kits 7x7 Biomax 022 Mbt 3, 4, 5 W/2800
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 05.04.0836Model Orthodontic Brackets
Identity
- Trade Name
- 100 KITS 7X7 BIOMAX 022 MBT 3,4,5 W/2800 EUDAMEDADITEK FDA UDI
- Generic Name
- Orthodontic bracket, metal FDA UDI
- Device Name
- 100 Kits 7x7 BioMax 022 MBT 3,4,5 w/2800 FDA UDI
- Model / Reference
- Orthodontic Brackets EUDAMED05.04.0836 EUDAMEDFDA UDI
- Description
- 100 Kits 7x7 BioMax 022 MBT 3,4,5 w/2800 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07899439293199 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
100 Kits 7x7 Biomax 022 Mbt 3, 4, 5 W/2800 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 9845b020-9cdd-4a5c-a189-8e074f8c7510 61 fields · synced Oct 5, 2026
- FDA UDI 61325803-0ce7-4f79-9f0b-83dcff58825d 33 fields · synced May 29, 2026