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E-Guard
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref RES-01-3213Model E-Guard510(k) K201173
Identity
- Trade Name
- E-Guard EUDAMED
- Device Name
- E-Guard EUDAMED
- Model / Reference
- E-Guard EUDAMEDRES-01-3213 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260683220119 EUDAMED
- Basic UDI-DI
- B-04260683220119 EUDAMED426068322EGUARD7W EUDAMED
- Direct Marketing DI
- 04260683220119 EUDAMED
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass 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-Guard by Envisiontec GmbH — Class IIa — FDA_510K, MDR, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K201173 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | B-04260683220119 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04260683220119 | Class IIa | Active |
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Manufacturer
- Manufacturer
- EnvisionTEC GmbH
- EUDAMED SRN
- DE-MF-000009311
Sources (3)
- EUDAMED 4792af22-06c0-43d2-b488-3ff706854289 85 fields · synced Jul 9, 2026
- EUDAMED 8b93b46c-5fb2-44cc-b3ff-fe907fc49a7d 61 fields · synced May 19, 2026
- FDA 510(k) K201173 1 fields · synced May 18, 2026