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Prone Positioner

by Ningbo KeRui Hygiene Product Co., Ltd

Ref GCP503_H(prone positioner_head)Model GCP503_H(prone positioner_head) GCP503_A(prone positioner_arm) GCP503_F(prone positioner_foot) GCP503_HS(prone positioner_head support) GCP503_FS(prone positioner_face shield) GCP503_AH(prone positioner_adult head)

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697589482KR012SQ Basic UDI-DI 06975894820819UDI-DIDate21 Aug 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  • Withdrawn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
Prone Positioner
Model / Reference
GCP503_H(prone positioner_head) GCP503_A(prone positioner_arm) GCP503_F(prone positioner_foot) GCP503_HS(prone positioner_head support) GCP503_FS(prone positioner_face shield) GCP503_AH(prone positioner_adult head), GCP503_H(prone positioner_head)
Primary DI / UDI-DI
06975894820819
Basic UDI-DI
697589482KR012SQ
EMDN Code
V9099 Various devices not included in other classes - other
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000017309
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Ningbo KeRui Hygiene Product Co., Ltd

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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