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OMS2050

by Zumax Medical CO., LTD. 16 variants

Ref 252V0741-R5

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Overview

The OMS2050 is a high-quality, Class I surgical microscope designed for precise and accurate observations in various medical procedures. Featuring advanced image enhancement technologies, this device provides unparalleled diagnostic capabilities for surgeons, anesthesiologists, and other medical professionals.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06945095526919 UDI-DI Date28 Oct 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number69450955microscope7G Basic UDI-DI 06945095526919UDI-DIDate10 Oct 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
OMS2050 EUDAMED
zumax GUDID
Generic Name
General-purpose surgical microscope
Model / Ref / Catalog
252V0741-R5, OMS2050
Primary DI / UDI-DI
06945095526919
Basic UDI-DI
69450955microscope7G
Direct Marketing DI
06945095526919
FDA Product Code
FSO
EMDN Code
Z12011101 Operative microscopes
GMDN Term
General-purpose surgical microscope
Device Class
Class I
Regulation Number
878.4700
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
252V0741-R5
GUDID
OMS2050

Manufacturer details

EUDAMED SRN
CN-MF-000011126
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Zumax Medical Co., LTD

See all devices from Zumax Medical Co., LTD →

Properties

  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No