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Pediatric Knee Crutches, Large (NC)

by MIZUHO Corporation EUDAMEDGUDID

Active European Union

Ref 08-070-16-NC

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number49463290208001U2 Basic UDI-DIDate12 Aug 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04946329218510 UDI-DIDate2 Jul 2021ListedStatusListed 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  • Withdrawn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
Pediatric Knee Crutches, Large (NC) EUDAMED
Pediatric Knee Crutches GUDID
Generic Name
Leg procedure positioner
Device Name
Knee Crutches, Pediatric Knee Crutches, Knee Crutches, Knee Crutches with Foot Support and Lithotomy Stirrups
Model / Ref / Catalog
08-070-16-NC
Primary DI / UDI-DI
04946329218510
Basic UDI-DI
49463290208001U2
Direct Marketing DI
04946329218510
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 — 408 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
  • Serial Number
  • Manufacturing Date

Other properties (19)

  • 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
  • Expiration Date: No