Identity
- Trade Name
- pIOMBox für C2 Xplore EUDAMED
- Device Name
- pIOMBox für C2 Xplore EUDAMED
- Model / Reference
- 540433 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250307610426 EUDAMED
- Basic UDI-DI
- 42503076IZC0138H EUDAMED
- EMDN Code
- Z12109080 VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class 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
Category: Orthopaedic trocar blade, reusable
pIOMBox für C2 Xplore by inomed Medizintechnik GmbH — Class I — 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 | K223254 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 42503076IZC0138H | Class I | Active |
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Manufacturer
- Manufacturer
- inomed Medizintechnik GmbH
- EUDAMED SRN
- DE-MF-000005589
Sources (2)
- EUDAMED 5ca6a944-b457-4fdb-bdce-edf3b8b104d3 61 fields · synced Jul 10, 2026
- FDA 510(k) K223254 1 fields · synced May 18, 2026