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Leg Plate (R2)

by MIZUHO Corporation EUDAMEDGUDID

Active European Union

Ref 08-078-20-R2

Overview

Unlock the full potential of your patient care with the Leg Plate (R2), a cutting-edge, Class I medical device designed for orthopedic surgery. This innovative product combines advanced materials and precision engineering to provide optimal support and stability for patients undergoing major procedures.

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number49463290208056UT Basic UDI-DIDate3 Sep 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04946329218558 UDI-DIDate12 Apr 2022ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Leg Plate (R2) EUDAMED
Leg plate GUDID
Generic Name
Leg procedure positioner
Device Name
Leg Plate, Kidney Bridge
Model / Ref / Catalog
08-078-20-R2
Primary DI / UDI-DI
04946329218558
Basic UDI-DI
49463290208056UT
Direct Marketing DI
04946329218558
FDA Product Code
GDC
EMDN Code
Z12011280 Patient positioning instruments - hardware accessories
GMDN Term
Leg procedure positioner
Device Class
Class I
Regulation Number
878.4960
Market of Registration
Romania
GUDID distribution status
In Commercial Distribution
Size
Length — 624 Millimeter

Manufacturer details

EUDAMED SRN
JP-MF-000019215
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Mizuho Corporation

See all devices from Mizuho Corporation →

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No