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Patient Positioning System

by Klarity Medical & Equipment(GZ) Co., Ltd. China EUDAMED

Ref R612-AE4Model Many

EMDN Z12011280

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number692082412141CM Basic UDI-DIDate1 Aug 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Patient Positioning System
Model / Reference
Many, R612-AE4
Primary DI / UDI-DI
06920824116463
Basic UDI-DI
692082412141CM
EMDN Code
Z12011280 Patient positioning instruments - hardware accessories
Device Class
Class I
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000002229
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Klarity Medical & Equipment(GZ) Co., Ltd.

See all devices from Klarity Medical & Equipment(GZ) Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED bf63c8c7-ee83-48aa-b139-06c3aa121e08 61 fields · synced 24 Oct 2026