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4K3D Video Microscope

by Mitaka Kohki Co., Ltd.

Ref HSModel HawkSight

4K3D Video Microscope (HS) is a general-purpose surgical microscope (EU MDR Class I; FDA Class I; FDA product code EPT, Microscope, Surgical) made by Mitaka Kohki Co., Ltd., registered in EUDAMED on 24 May 2023 (Basic UDI-DI 458969845060Q6) and listed in FDA GUDID since 30 Nov 2022 (UDI-DI 04589698450602), 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 Number458969845060Q6 Basic UDI-DI 04589698450602UDI-DIDate24 May 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number04589698450602 UDI-DI Date30 Nov 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 458969845060Q6 registered 24 May 2023 Active
  • FDA GUDID UDI-DI 04589698450602 listed 30 Nov 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04589698450602
  2. Registered EUDAMED 458969845060Q6

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  • Withdrawn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
4K3D Video Microscope EUDAMED
4K3D Video Microscope HawkSight GUDID
Generic name
General-purpose surgical microscope
Model / reference
HawkSight EUDAMED
HS EUDAMED
KV3 GUDID
Primary DI / UDI-DI
04589698450602
Basic UDI-DI
458969845060Q6
Direct marketing DI
04589698450602
FDA product code
EPT
EMDN code
Z12011101 Operative microscopes
GMDN term
General-purpose surgical microscope
Device class
Class I
Regulation number
878.4700
EU registration type
Standard device
EU market of registration
Czechia
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
HawkSight
HS
GUDID
KV3

Manufacturer details

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

Similar devices in this category

Other devices filed under OPERATIVE MICROSCOPES.

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Properties

  • Premarket exempt
  • Serial number
Other properties (23, all answered No)