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Rails

by Zhongshan Sunneo Medical Instruments Co., Ltd.

Ref DR3400001Model DR3400001、DR3400002、DR3400003、DR3400004、DR3400005、DR3400006、DR3400007、DR3400008、DR3400009、DR340010、DR3400011、DR3400012、etc

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 Number697830501Rails3V Basic UDI-DI 06978305016009UDI-DIDate26 Feb 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  • Withdrawn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
Rails
Model / Reference
DR3400001、DR3400002、DR3400003、DR3400004、DR3400005、DR3400006、DR3400007、DR3400008、DR3400009、DR340010、DR3400011、DR3400012、etc, DR3400001
Primary DI / UDI-DI
06978305016009
Basic UDI-DI
697830501Rails3V
EMDN Code
Y181809 Armrests
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000039352
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Zhongshan Sunneo Medical Instruments Co Ltd

See all devices from Zhongshan Sunneo Medical Instruments Co 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