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EP-Adapter zu 504281 an ISIS Headbox 16Ch.REF-AEP
EUDAMEDFDA UDIClass I (EU MDR)
Ref 540522
Identity
- Trade Name
- EP-Adapter zu 504281 an ISIS Headbox 16Ch.REF-AEP EUDAMEDISIS FDA UDI
- Generic Name
- Nerve-function monitor FDA UDI
- Device Name
- EP-Adapter zu 504281 an ISIS Headbox 16Ch.REF-AEP EUDAMEDEP Adaptor for ISIS Headbox 16Ch.REF-AEP FDA UDI
- Model / Reference
- 540522 EUDAMEDFDA UDI
- Description
- EP Adaptor for ISIS Headbox 16Ch.REF-AEP FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250307608942 EUDAMEDFDA UDI
- Basic UDI-DI
- 42503076IZB01084 EUDAMED
- FDA Product Code
- GWF 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
- 882.1870 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
Yes
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
MR Unsafe FDA UDI
Category: Orthopaedic trocar blade, reusable
EP-Adapter zu 504281 an ISIS Headbox 16Ch.REF-AEP by inomed Medizintechnik GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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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 | 42503076IZB01084 | 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 91ceec06-ef2b-4519-885f-7584f57fbaaa 61 fields · synced Jun 18, 2026
- FDA UDI 806f4e8a-1a96-4c7c-bb20-785d13ae3b50 33 fields · synced May 30, 2026