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Boot Pad for Levitator Stirrup II, Wide, Left Leg

by MIZUHO Corporation

Ref 18-070-48

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number49463290318009VA Basic UDI-DI 04946329387650UDI-DIDate18 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04946329387650 UDI-DI Date20 Oct 2023ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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

Generic Name
Leg procedure positioner
Model / Ref / Catalog
18-070-48
Primary DI / UDI-DI
04946329387650
Basic UDI-DI
49463290318009VA
Direct Marketing DI
04946329387650
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
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Length — 440 Millimeter

Manufacturer details

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

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Properties

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

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: 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