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EM Registration Pointer

by Brainlab SE

Ref 18099-23

EM Registration Pointer (18099-23) is a device classified as Class I in the EU and Class II in the US made by Brainlab SE, registered in EUDAMED on 23 Apr 2024 (Basic UDI-DI 4056481EMRegPointerVW), cleared under FDA 510(k) K223734 on 27 Apr 2023 (1 earlier submission) and listed in FDA GUDID since 15 Sep 2016 (UDI-DI 04056481004811), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K223734

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4056481EMRegPointerVW Basic UDI-DI 04056481004811UDI-DIDate23 Apr 2024RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK223734 Date27 Apr 2023DecidedStatusActive
United StatesGUDID listing GUDID Number04056481004811 UDI-DI Date15 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 4056481EMRegPointerVW registered 23 Apr 2024 Active
  • FDA 510(k) K223734 decided 27 Apr 2023 Active· +1 more in the status table
  • FDA GUDID UDI-DI 04056481004811 listed 15 Sep 2016 Listed

Timeline

4 dated events

  1. Listed FDA GUDID 04056481004811
  2. Cleared FDA 510(k) K213989
  3. Cleared FDA 510(k) K223734
  4. Registered EUDAMED 4056481EMRegPointerVW

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Electromagnetic/optical surgical navigation/tracking system
Model / Ref / Catalog
18099-23
Primary DI / UDI-DI
04056481004811
Basic UDI-DI
4056481EMRegPointerVW
Direct marketing DI
04056481004811
510(k) Number
FDA product code
HAW, PGW
EMDN code
Z12011480 Surgical navigation instruments - hardware accessories
GMDN term
Electromagnetic/optical surgical navigation/tracking system
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.4560
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
DE-MF-000006183

Related devices

Category: Neurological stereotactic surgery system

Similar devices in this category

Other devices filed under SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Brainlab SE

See all devices from Brainlab SE →

Properties

  • Prescription use
  • Serial number
Other properties (23, all answered No)