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Ultra Shoulder Positioner with Cart

by Mizuho Orthopedic Systems, Inc.

Ref 5370

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0842430158956Y Basic UDI-DI 00842430113031UDI-DIDate2 May 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Operating Table Accessories
Model / Reference
5370
Primary DI / UDI-DI
00842430113031
Basic UDI-DI
0842430158956Y
EMDN Code
Z12011299 Patient positioning instruments – other
Device Class
Class I
EU market of registration
Finland

Manufacturer details

EUDAMED SRN
US-MF-000002901
Authorised representative
Emergo Europe B.V. NL-AR-000000116

From the manufacturer

Manufacturer's product page: Ultra Shoulder Positioner®

Other devices from Mizuho Orthopedic Systems, Inc.

See all devices from Mizuho Orthopedic Systems, Inc. →

Properties

Other properties (13)

  • Sterile: 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