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Surgical Microscope

by Mitaka Kohki Co., Ltd. 2 variants

Ref MM51/YOH

Surgical Microscope (MM51/YOH) is a surgical microscope fluorescent angiography system (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 458969845017Q5) and listed in FDA GUDID since 3 Sep 2018 (UDI-DI 04589698450176), 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 Number458969845017Q5 Basic UDI-DI 04589698450176UDI-DIDate24 May 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number04589698450176 UDI-DI Date3 Sep 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 458969845017Q5 registered 24 May 2023 Active
  • FDA GUDID UDI-DI 04589698450176 listed 3 Sep 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04589698450176
  2. Registered EUDAMED 458969845017Q5

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  • Withdrawn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
Surgical Microscope EUDAMED
Surgical Microscope MM51/YOH GUDID
Generic name
Surgical microscope fluorescent angiography system
Model / reference
MM51/YOH
Primary DI / UDI-DI
04589698450176
Basic UDI-DI
458969845017Q5
Direct marketing DI
04589698450176
FDA product code
EPT
EMDN code
Z12011101 Operative microscopes
GMDN term
Surgical microscope fluorescent angiography system
Device class
Class I
Regulation number
878.4700
EU registration type
Standard device
EU market of registration
Czechia
GUDID distribution status
In Commercial Distribution

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.

Other devices from Mitaka Kohki Co., Ltd.

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

Properties

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