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Customized Surgical Microscope Component M Custom

by Global Surgical Corp.

Ref M CUSTOMModel Global Surgical Operating Microscope System

Customized Surgical Microscope Component M Custom is a Class I device made by Global Surgical Corp., registered in EUDAMED on 29 Sep 2026 (Basic UDI-DI 081004025GSOMSWD) and listed in FDA GUDID since 21 Sep 2021 (UDI-DI 00810040253898), 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 Number081004025GSOMSWD Basic UDI-DI 00810040253898UDI-DIDate29 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00810040253898 UDI-DI Date21 Sep 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081004025GSOMSWD registered 29 Sep 2026 Active
  • FDA GUDID UDI-DI 00810040253898 listed 21 Sep 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00810040253898
  2. Registered EUDAMED 081004025GSOMSWD

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  • Withdrawn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
Customized Surgical Microscope Component
Generic name
General-purpose surgical microscope
Model / reference
M CUSTOM, Global Surgical Operating Microscope System
Primary DI / UDI-DI
00810040253898
Basic UDI-DI
081004025GSOMSWD
Direct marketing DI
00810040253898
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
Netherlands
GUDID distribution status
In Commercial Distribution

Related devices

Category: General-purpose surgical microscope

Similar devices in this category

Other devices filed under OPERATIVE MICROSCOPES.

Other devices from Global Surgical Corp.

See all devices from Global Surgical Corp. →

Properties

  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)