Skip to content

PoinSetter

by Mitaka Kohki Co., Ltd.

Ref PSMS-2

PoinSetter (PSMS-2) is a surgical instrument assist arm system (EU MDR Class I; FDA Class II) made by Mitaka Kohki Co., Ltd., registered in EUDAMED on 4 Jul 2023 (Basic UDI-DI 458969845001PN) and listed in FDA GUDID since 17 Oct 2016 (UDI-DI 04589698450015), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number458969845001PN Basic UDI-DI 04589698450015UDI-DIDate4 Jul 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number04589698450015 UDI-DI Date17 Oct 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 458969845001PN registered 4 Jul 2023 Active
  • FDA GUDID UDI-DI 04589698450015 listed 17 Oct 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04589698450015
  2. Registered EUDAMED 458969845001PN

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
PoinSetter EUDAMED
Point Setter GUDID
Generic name
Surgical instrument assist arm system, power-adjusted
Model / reference
PSMS-2
Primary DI / UDI-DI
04589698450015
Basic UDI-DI
458969845001PN
Direct marketing DI
04589698450015
FDA product code
GWG, GCJ
EMDN code
Z12029099 Various instruments for endoscopy and mini–invasive surgery – other
GMDN term
Surgical instrument assist arm system, power-adjusted
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.1480, 876.1500
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

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
JP-MF-000013028
Authorised representative
Mitaka Europe GmbH DE-AR-000006361

Similar devices in this category

Other devices filed under VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI–INVASIVE SURGERY – OTHER.

Other devices from Mitaka Kohki Co., Ltd.

See all devices from Mitaka Kohki Co., Ltd. →

Properties

  • Sterilise before use
  • Prescription use
  • Serial number
Other properties (22, all answered No)