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neuromate - Tool guide OD15 - Microdrive AlphaOmega

by Renishaw Mayfield EUDAMEDGUDID

Active European Union

Ref 003.0163

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number03662724000611 UDI-DIDate14 Jul 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number3662724nmtoolguideMV Basic UDI-DIDate3 Jun 2026RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
neuromate - Tool guide OD15 - Microdrive AlphaOmega EUDAMED
neuromate - Tool guide GUDID
Generic Name
Neurological stereotactic surgery system
Device Name
neuromate tool guides
Model / Ref / Catalog
003.0163, OD15 - Microdrive AlphaOmega
Primary DI / UDI-DI
03662724000611
Basic UDI-DI
3662724nmtoolguideMV
Direct Marketing DI
03662724000611
FDA Product Code
HAW
EMDN Code
Z12100680 Stereotactic neurosurgery instruments - hardware accessories
GMDN Term
Neurological stereotactic surgery system
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
882.4560
Market of Registration
France
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
003.0163
GUDID
OD15 - Microdrive AlphaOmega
Device ClassEUDAMED
Class I
GUDID
Class II

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Properties

  • Lot / Batch Number

Other properties (23)

  • 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
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No