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Metal Brackets
EUDAMEDClass IIa (EU MDR)
Ref KIT21-321-03CBCHKModel Self-Ligating Bracket
Identity
- Trade Name
- Metal Brackets EUDAMED
- Model / Reference
- Self-Ligating Bracket EUDAMEDKIT21-321-03CBCHK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06957067068013 EUDAMED
- Basic UDI-DI
- 695706706518-6669TA EUDAMED
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Metal Brackets by Innovative Material and Devices, Inc — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 695706706518-6669TA | Class IIa | Active |
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Manufacturer
- Manufacturer
- Innovative Material and Devices, Inc
- EUDAMED SRN
- CN-MF-000002280
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 70fb0eb5-0c87-4b60-b6f5-b3944d9bc608 61 fields · synced Jun 18, 2026