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Flexcera Smile Ultra+ A1 0.5kg
EUDAMEDClass IIa (EU MDR)
Ref RES-01-3282Model Flexcera Smile Ultra+
Identity
- Trade Name
- Flexcera Smile Ultra+ A1 0.5kg EUDAMED
- Device Name
- Flexcera Smile Ultra+ EUDAMED
- Model / Reference
- Flexcera Smile Ultra+ EUDAMEDRES-01-3282 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260683220737 EUDAMED
- Basic UDI-DI
- 426068322FLEXCERASMILEU74 EUDAMED
- Direct Marketing DI
- 04260683220737 EUDAMED
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER 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
Flexcera Smile Ultra+ A1 0.5kg by Envisiontec GmbH — 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 | 426068322FLEXCERASMILEU74 | Class IIa | Active |
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Manufacturer
- Manufacturer
- EnvisionTEC GmbH
- EUDAMED SRN
- DE-MF-000009311
Sources (1)
- EUDAMED b0338cc6-0594-48f2-9893-dfac6b54e74e 61 fields · synced Jul 22, 2026