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Pointer ST

by Localite GmbH

Ref 002009Model Pointer

Pointer ST (002009) is a stereotactic neuronavigation/planning system (EU MDR Class I; FDA Class II; FDA product code HAW, Neurological Stereotaxic Instrument) made by LOCALITE GmbH, registered in EUDAMED on 20 Apr 2023 (Basic UDI-DI ++G076J19L), cleared under FDA 510(k) K223577 on 17 Apr 2023 and listed in FDA GUDID since 5 Jul 2023 (UDI-DI +G076A002009A0F), 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) K223577

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number+G076A002009A0F UDI-DI Date5 Jul 2023ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number++G076J19L Basic UDI-DI +G076A002009A0FUDI-DIDate20 Apr 2023RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK223577 Date17 Apr 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI ++G076J19L registered 20 Apr 2023 Active
  • FDA 510(k) K223577 decided 17 Apr 2023 Active
  • FDA GUDID UDI-DI +G076A002009A0F listed 5 Jul 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K223577
  2. Registered EUDAMED ++G076J19L
  3. Listed FDA GUDID +G076A002009A0F

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  • Withdrawn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

Trade name
Pointer ST EUDAMED
Localite TMS Navigator TS GUDID
Generic name
Stereotactic neuronavigation/planning system
Device name
Pointer
Model / Ref / Catalog
Pointer, 002009, Pointer ST
Primary DI / UDI-DI
+G076A002009A0F EUDAMED
G076A002009A0 GUDID
Basic UDI-DI
++G076J19L
510(k) Number
FDA product code
HAW
EMDN code
V9099 Various devices not included in other classes - other
GMDN term
Stereotactic neuronavigation/planning 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 · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Pointer
002009
GUDID
Pointer ST
Primary DI / UDI-DIEUDAMED
+G076A002009A0F
GUDID
G076A002009A0
Device classEUDAMED
Class I
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists +G076A002009A0F; FDA GUDID lists G076A002009A0), so their flags are not compared. 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-000005419

Related devices

Category: Device sterilization/disinfection container, reusable

Similar devices in this category

Other devices filed under VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER.

Other devices from LOCALITE GmbH

See all devices from LOCALITE GmbH →

Properties

  • Serial number
Other properties (24, all answered No)