Identity
- Trade Name
- Flexcera Smile A3.5 EUDAMED
- Device Name
- Flexcera Smile EUDAMED
- Model / Reference
- RES-01-3237 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260683220553 EUDAMED
- Basic UDI-DI
- 426068322FLEXCERASMILEYJ EUDAMED
- Direct Marketing DI
- 04260683220553 EUDAMED
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I 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 A3.5 by Envisiontec GmbH — 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 | 426068322FLEXCERASMILEYJ | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- EnvisionTEC GmbH
- EUDAMED SRN
- DE-MF-000009311
Sources (1)
- EUDAMED 121a6bb8-49df-49d5-b81b-51a9039712f9 61 fields · synced Jul 12, 2026