Identity
- Device Name
- FOKALDRY Solution EUDAMED
- Model / Reference
- 0032305 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 111669972351 EUDAMED
- Basic UDI-DI
- B-111669972351 EUDAMED
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
FOKALDRY Solution by lege artis Pharma GmbH + Co. KG — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-111669972351 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- lege artis Pharma GmbH + Co. KG
- EUDAMED SRN
- DE-MF-000006175
Sources (1)
- EUDAMED 5db7f8ef-ce5c-4e65-8148-9c9bdf4c3ecb 61 fields · synced Oct 6, 2026