Identity
- Trade Name
- C2 Xplore EUDAMEDFDA UDI
- Generic Name
- Nerve-function monitor FDA UDI
- Device Name
- C2 Xplore EUDAMED
- Model / Reference
- 508288 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250307610228 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250307610228 EUDAMED
- FDA Product Code
- ETN FDA UDIGWF FDA UDI
- EMDN Code
- Z121002 NERVOUS SYSTEM MONITORING SYSTEMS EUDAMED
- GMDN Term
- Nerve-function monitor FDA UDI
Classification
- Device Class
- Class IIa 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
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
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: Nerve-function monitor
C2 Xplore by inomed Medizintechnik GmbH — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Nerve-function monitor.
- SENTIO — Medos International Sàrl · Class II
- ISIS — inomed Medizintechnik GmbH · Class II
- ISIS — inomed Medizintechnik GmbH · Class II
- ISIS — inomed Medizintechnik GmbH · Class II
- ISIS — inomed Medizintechnik GmbH · Class II
- ISIS — inomed Medizintechnik GmbH · Class II
- ISIS — inomed Medizintechnik GmbH · Class II
- ISIS — inomed Medizintechnik GmbH · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- inomed Medizintechnik GmbH
Sources (2)
- FDA UDI b13fa91e-e218-4f85-a524-b39f91a4da27 32 fields · synced Jul 9, 2026
- EUDAMED c65d9aa8-1fc0-4da4-9af9-3d22bb343387 61 fields · synced Jul 9, 2026