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Joystick-control Units

by Fengh Medical Co., Ltd.

Ref FH28ARModel Device Model：AR1，AR2；Components Model：ARRC，ARE1，ARE2，IE-L，IE-R ，PDM，MPS.

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69213483FH28A0182 Basic UDI-DI 06921348332100UDI-DIDate14 Jul 2026RegisteredStatusActive

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  • Withdrawn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
Motorized Positioning System for Endoscopic Surgery
Model / Reference
Device Model：AR1，AR2；Components Model：ARRC，ARE1，ARE2，IE-L，IE-R ，PDM，MPS., FH28AR
Primary DI / UDI-DI
06921348332100
Basic UDI-DI
69213483FH28A0182
EMDN Code
Z1202018001 Robotic arms for videoendoscopy
Device Class
Class I
EU market of registration
Northern Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000004718
Authorised representative
Wellkang Ltd XI-AR-000001836

Other devices from Fengh Medical Co., Ltd.

See all devices from Fengh Medical 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