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Safety Handrails

by Zhongshan First Medical Equipment Co., Ltd 3 variants

Ref FST1215AModel FST1210、FST1215、FST1217、FST1218、FST1219、FST1225、FST1226、FST131、FST135、FST137 、FST9200、FST9600、FST9203、FST9107、FST9100、FST9201、FST9206、FST9205、FST9226、FST9228 or customized

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 Number697584560FST009SG Basic UDI-DI 06975845602624UDI-DIDate18 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  • Withdrawn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
Safety Handrails
Model / Reference
FST1210、FST1215、FST1217、FST1218、FST1219、FST1225、FST1226、FST131、FST135、FST137 、FST9200、FST9600、FST9203、FST9107、FST9100、FST9201、FST9206、FST9205、FST9226、FST9228 or customized, FST1215A
Primary DI / UDI-DI
06975845602624
Basic UDI-DI
697584560FST009SG
EMDN Code
Y181809 Armrests
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000044385
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Zhongshan First Medical Equipment 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