Identity
- Trade Name
- SCS MedSeries® H50 EUDAMED
- Device Name
- Planmed XFI EUDAMED
- Model / Reference
- FE005364 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06430035430154 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
SCS MedSeries® H50 by Planmed Oy — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Electromagnetic surgical navigation device tracking system.
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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 | 6430035430045S | Class IIb | Active |
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Manufacturer
- Manufacturer
- Planmed Oy
- EUDAMED SRN
- FI-MF-000006837
Sources (1)
- EUDAMED 50f85549-9a8d-4d8a-8676-10aca1e2f4c1 61 fields · synced Jul 12, 2026