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Planmed XFI
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref 30022041510(k) K250318
by Planmed Oy
Identity
- Device Name
- Planmed XFI EUDAMED
- Model / Reference
- 30022041 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06430035430130 EUDAMED
- Basic UDI-DI
- 6430035430045S EUDAMED
- EMDN Code
- Z11039099 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS – OTHER 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
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
Category: Electromagnetic surgical navigation device tracking system
Planmed XFI by Planmed Oy — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250318 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 6430035430045S | Class IIb | Active |
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Manufacturer
- Manufacturer
- Planmed Oy
- EUDAMED SRN
- FI-MF-000006837
Sources (2)
- EUDAMED d4ca3e91-8811-411b-b6ed-0e5f8f2ace61 85 fields · synced Jun 18, 2026
- FDA 510(k) K250318 1 fields · synced May 18, 2026