Identity
- Trade Name
- FOCUS™ OPENMOUNT™ EUDAMED
- Device Name
- FOCUS OPENMOUNT EUDAMED
- Model / Reference
- Focus EUDAMED901188 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06430035873029 EUDAMED
- Basic UDI-DI
- B-06430035873029 EUDAMED
- EMDN Code
- Z1103040102 EQUIPMENT FOR DIGITAL ENDORAL RADIOLOGY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Finland 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
Focus™ Openmount™ by PaloDEx Group Oy — Class IIb — 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-06430035873029 | Class IIb | Active |
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Manufacturer
- Manufacturer
- PaloDEx Group Oy
- EUDAMED SRN
- FI-MF-000004943
Sources (1)
- EUDAMED 114d7549-4d97-485c-a76b-f40bfd60c398 61 fields · synced Jul 21, 2026