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Shoulder Supports

by MIZUHO Corporation EUDAMEDGUDID

Active European Union

Ref 08-068-04

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number49463290208006UC Basic UDI-DIDate13 Aug 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04946329171563 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  • Withdrawn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
Shoulder Supports EUDAMED
Shoulder Support GUDID
Generic Name
Operating table torso positioner
Model / Ref / Catalog
08-068-04
Primary DI / UDI-DI
04946329171563
Basic UDI-DI
49463290208006UC
Direct Marketing DI
04946329171563
FDA Product Code
GDC
EMDN Code
Z12011280 Patient positioning instruments - hardware accessories
GMDN Term
Operating table torso positioner
Device Class
Class I
Regulation Number
878.4960
Market of Registration
Romania
GUDID distribution status
In Commercial Distribution
Size
Length — 260 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