Grid-/TES-Stimulationsmatrix 16 Ch. an ISIS Neurostimulator
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Grid-/TES-Stimulationsmatrix 16 Ch. an ISIS Neurostimulator EUDAMEDISIS FDA UDI
- Generic Name
- Nerve-function monitor FDA UDI
- Device Name
- Grid-/TES-Stimulationsmatrix EUDAMEDSEP-Stimulationsadapter an ISIS Neurostimulator EUDAMEDGrid/TES Stimulation matrix 16 Ch. for ISIS Neurostimulator FDA UDI
- Model / Reference
- 540559 EUDAMED540560 EUDAMEDFDA UDI540501 EUDAMED540550 EUDAMED
- Description
- Grid/TES Stimulation matrix 16 Ch. for ISIS Neurostimulator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250307609147 EUDAMEDFDA UDI04250307604692 EUDAMED
- Basic UDI-DI
- 42503076IZB0608K EUDAMED42503076IZB02087 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
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Orthopaedic trocar blade, reusable
Grid-/TES-Stimulationsmatrix 16 Ch. an ISIS Neurostimulator by inomed Medizintechnik GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 42503076IZB0608K | 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 (3)
- EUDAMED a7a79bcb-246e-42f9-af46-c6e9562f9ff3 61 fields · synced Oct 6, 2026
- FDA UDI 245506ae-acce-47cc-ba48-3e7c55e6b698 33 fields · synced May 30, 2026
- EUDAMED 84364346-20de-4608-928d-79ede64be4f4 61 fields · synced Jul 10, 2026