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Orthodontic bands and attachments
EUDAMEDClass IIa (EU MDR)
Ref 81-622-320Ref 81-611-445
Identity
- Device Name
- Orthodontic bands and attachments EUDAMED
- Model / Reference
- 81-622-320 EUDAMED81-611-445 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936949215127 EUDAMED06936949215110 EUDAMED
- Basic UDI-DI
- 693694922001-3197RG EUDAMED693694921786-22082F EUDAMED
- EMDN Code
- Q010402 ORTHODONTIC BANDS 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
Orthodontic bands and attachments 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 | 693694922001-3197RG | 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 (2)
- EUDAMED b154f844-bf7f-4513-a2b5-f7a5cbf79599 61 fields · synced Jul 18, 2026
- EUDAMED fa3e274a-a3ad-4149-893b-39002ea4b75b 61 fields · synced May 18, 2026