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EM Pointer

by Brainlab SE

Ref 18099-02C

EM Pointer (18099-02C) is a device classified as Class IIa in the EU and Class II in the US made by Brainlab SE, registered in EUDAMED on 24 Feb 2025 (Basic UDI-DI 4056481EMPointersR7), cleared under FDA 510(k) K223734 on 27 Apr 2023 (1 earlier submission) and listed in FDA GUDID since 15 Sep 2016 (UDI-DI 04056481004927), 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 Number4056481EMPointersR7 Basic UDI-DI 04056481004927UDI-DIDate24 Feb 2025RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK223734 Date27 Apr 2023DecidedStatusActive
United StatesGUDID listing GUDID Number04056481004927 UDI-DI Date15 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 4056481EMPointersR7 registered 24 Feb 2025 Active
  • FDA 510(k) K223734 decided 27 Apr 2023 Active· +1 more in the status table
  • FDA GUDID UDI-DI 04056481004927 listed 15 Sep 2016 Listed

Timeline

4 dated events

  1. Listed FDA GUDID 04056481004927
  2. Cleared FDA 510(k) K213989
  3. Cleared FDA 510(k) K223734
  4. Registered EUDAMED 4056481EMPointersR7

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  • Withdrawn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
Device name
EM Pointers
Model / Ref / Catalog
18099-02C
Primary DI / UDI-DI
04056481004927
Basic UDI-DI
4056481EMPointersR7
Direct marketing DI
04056481004927
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 IIa EUDAMED
Class II GUDID
Regulation number
882.4560
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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

  • Sterilise before use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Contains endocrine-disrupting substances
  • Serial number
Other properties (21, all answered No)