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BrainLab NaviVision Sleeve Guide

by Ad-Tech Medical Instrument Corp. EUDAMEDGUDID

Active European Union

Ref BLNG-2X

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08418231RA11bBW Basic UDI-DIDate2 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841823100733 UDI-DIDate31 Aug 2023ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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 24 Oct 2026.

Specification

EUDAMED · GUDID

Generic Name
Neurological stereotactic surgery system
Device Name
Placement and Accessories – Class Is/Im Devices
Model / Ref / Catalog
BLNG-2X
Primary DI / UDI-DI
00841823100733
Basic UDI-DI
08418231RA11bBW
FDA Product Code
FZX
EMDN Code
N010180 Neurophysiology devices - accessories
GMDN Term
Neurological stereotactic surgery system
Device Class
Class I
Regulation Number
878.4800
Market of Registration
Ireland
GUDID distribution status
In Commercial Distribution
Sterilization Method
Ethylene Oxide

Manufacturer details

EUDAMED SRN
US-MF-000004795
Authorised representative
E C REP LIMITED IE-AR-000003995

Other devices from Ad-Tech Medical Instrument Corp.

See all devices from Ad-Tech Medical Instrument Corp. →

Properties

  • Sterile
  • Reusable
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • Single Use: No
  • Implantable: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No