neuromate neuroinspire software
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- neuroinspire planning software EUDAMEDneuromate neuroinspire software FDA UDI
- Generic Name
- Neurological stereotactic surgery system FDA UDI
- Device Name
- neuroinspire planning software EUDAMED
- Model / Reference
- 001.0142 EUDAMEDneuroinspire planning software FDA UDI
Identifiers
- Catalog Number
- 001.0142 FDA UDI
- Primary DI / UDI-DI
- 03662724000390 EUDAMEDFDA UDI
- Basic UDI-DI
- 3662724nmsoftware3B EUDAMED
- Direct Marketing DI
- 03662724000390 EUDAMED
- FDA Product Code
- HAW FDA UDI
- EMDN Code
- Z12100692 STEREOTACTIC NEUROSURGERY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Neurological stereotactic surgery system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- France 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
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Neurological stereotactic surgery system
neuromate neuroinspire software by Renishaw Mayfield — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Renishaw Mayfield
Sources (2)
- FDA UDI 88ee3a4a-7b46-4b25-b3c0-5458c7c65cd4 33 fields · synced Jun 19, 2026
- EUDAMED c487f282-8f64-4cce-9588-36c381c661ed 61 fields · synced Jun 19, 2026