Identity
- Trade Name
- Body Box für C2 Xplore EUDAMEDC2 Xplore FDA UDI
- Generic Name
- Nerve-function monitor FDA UDI
- Device Name
- Body Box für C2 Xplore EUDAMEDBody Box for C2 Xplore FDA UDI
- Model / Reference
- 540431 EUDAMEDFDA UDI
- Description
- Body Box for C2 Xplore FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250307610402 EUDAMEDFDA UDI
- Basic UDI-DI
- 42503076IZC0118D EUDAMED
- FDA Product Code
- ETN FDA UDIGWF FDA UDI
- EMDN Code
- Z12109080 VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Nerve-function monitor FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 874.1820 FDA UDI882.1870 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthopaedic trocar blade, reusable
Body Box für C2 Xplore by inomed Medizintechnik GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 42503076IZC0118D | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- inomed Medizintechnik GmbH
- EUDAMED SRN
- DE-MF-000005589
Sources (2)
- EUDAMED 300de03e-ca59-464c-84df-8085b1df89d5 61 fields · synced Jun 18, 2026
- FDA UDI 3df416f0-cecd-4427-a055-200c95603393 33 fields · synced May 30, 2026