Identity
- Trade Name
- Flexcera Base Ultra+ Dark Pink EUDAMED
- Device Name
- Flexcera Base Ultra+ EUDAMED
- Model / Reference
- RES-01-3602 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260683220980 EUDAMED
- Basic UDI-DI
- 426068322FLEXCERABUPLUS5U EUDAMED
- Direct Marketing DI
- 04260683220980 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 Base Ultra+ Dark Pink 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 | 426068322FLEXCERABUPLUS5U | Class I | Active |
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Manufacturer
- Manufacturer
- EnvisionTEC GmbH
- EUDAMED SRN
- DE-MF-000009311
Sources (1)
- EUDAMED 0796b4d4-53f0-4375-98bd-a7bd1129c95f 61 fields · synced Jun 19, 2026