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Flexcera Smile Ultra+ A2 1kg for Carbon
EUDAMEDClass IIa (EU MDR)
Ref RES-01-3447Model Flexcera Smile Ultra+Ref RES-01-3247
Identity
- Trade Name
- Flexcera Smile Ultra+ A2 1kg for Carbon EUDAMEDFlexcera Smile Ultra+ A2 1kg EUDAMED
- Device Name
- Flexcera Smile Ultra+ EUDAMED
- Model / Reference
- Flexcera Smile Ultra+ EUDAMEDRES-01-3447 EUDAMEDRES-01-3247 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260683220898 EUDAMED04260683220683 EUDAMED
- Basic UDI-DI
- 426068322FLEXCERASMILEU74 EUDAMED
- Direct Marketing DI
- 04260683220898 EUDAMED04260683220683 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+ A2 1kg for Carbon 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 (2)
- EUDAMED 24a791f9-42be-40f4-826a-f1e4cd3f0b61 61 fields · synced Jul 17, 2026
- EUDAMED 7aa6084c-6409-4074-a031-8c43bf88926d 61 fields · synced May 17, 2026