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Metal Brackets
EUDAMEDClass IIa (EU MDR)
Ref 21-211-43HKModel Self-Ligating Bracket
Identity
- Trade Name
- Metal Brackets EUDAMED
- Model / Reference
- Self-Ligating Bracket EUDAMED21-211-43HK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06957067065364 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
Metal Brackets by Innovative Material and Devices, Inc — 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 | 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 963c2f50-d784-4d8c-a85f-c929f853cc92 61 fields · synced Jun 18, 2026