Identity
- Trade Name
- E-Guide EUDAMED
- Device Name
- E-Guide EUDAMED
- Model / Reference
- E-Guide EUDAMEDRES-01-3212 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260683220126 EUDAMED
- Basic UDI-DI
- 426068322EGUIDE7W EUDAMED
- Direct Marketing DI
- 04260683220126 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
E-Guide 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 | 426068322EGUIDE7W | Class I | Active |
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Manufacturer
- Manufacturer
- EnvisionTEC GmbH
- EUDAMED SRN
- DE-MF-000009311
Sources (1)
- EUDAMED e0c4b7ef-6949-4a28-87dd-2d22fcb1f808 61 fields · synced May 22, 2026