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Orthodontic Face Mask
EUDAMEDClass I (EU MDR)
Ref Large blueModel Large/Small Ref Large mixRef Large blue glitterRef Large red
Identity
- Trade Name
- Orthodontic Face Mask EUDAMED
- Device Name
- Orthodontic Face Mask EUDAMED
- Model / Reference
- Large/Small EUDAMEDLarge blue EUDAMEDLarge mix EUDAMEDLarge blue glitter EUDAMEDLarge red EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974435054638 EUDAMED06974435054645 EUDAMED06942665511931 EUDAMED06974435054652 EUDAMED
- Basic UDI-DI
- 697443505FaceMaskBZ EUDAMED
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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 Face Mask by Creative Dental — Class I — 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 | 697443505FaceMaskBZ | Class I | Active |
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Manufacturer
- Manufacturer
- Creative Dental
- EUDAMED SRN
- CN-MF-000025975
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (8)
- EUDAMED 2f9ae76b-ae0d-4cbf-a1bd-efb31ca1b265 61 fields · synced Jul 27, 2026
- EUDAMED cb239d5a-24b1-4be0-a56b-d07c10febea6 61 fields · synced May 18, 2026
- EUDAMED 2541f30c-fb80-43e7-b636-db7d8186bd70 61 fields · synced May 18, 2026
- EUDAMED b627696c-2971-4a93-b298-76e67ffc64cc 61 fields · synced May 19, 2026
- EUDAMED 9ae9ae6b-22d4-4dc3-b1be-d9df429adb45 61 fields · synced Jul 9, 2026
- EUDAMED 499bc56d-a8c7-4321-8141-056b6b548b49 61 fields · synced Jul 11, 2026
- EUDAMED 61b6bbb4-291a-4d84-a011-d9027639927e 61 fields · synced Jul 15, 2026
- EUDAMED 3e6f0121-3f55-4802-a446-a9c9b8ee62e2 61 fields · synced Jul 27, 2026