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Disposable Surgical Patient Positioning Accessories

by Premier Guard Zhongshan Ltd. 17 variants

Ref 14-3101NModel 14-1120N

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69592217G001NX Basic UDI-DI 06959221713623UDI-DIDate31 Oct 2025RegisteredStatusActive

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  • Withdrawn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
Disponsable Surgical Patient Positioning Accessories
Model / Reference
14-1120N, 14-3101N
Primary DI / UDI-DI
06959221713623
Basic UDI-DI
69592217G001NX
EMDN Code
V080302 Patient positioning medical cushions
Device Class
Class I
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000008071
Authorised representative
Wellkang Ltd XI-AR-000001836

Other devices from Premier Guard Zhongshan Ltd.

See all devices from Premier Guard Zhongshan Ltd. →

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