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Disposable Endoscopic Linear Cutter Stapler

by Fengh Medical Co., Ltd. EUDAMED

Active European Union

Ref FH01Model FAES45、FAES60、FAEM45、FAEM60、FAEL45、FAEL60

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69213483FH0103E4S Basic UDI-DIDate17 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Model / Reference
FAES45、FAES60、FAEM45、FAEM60、FAEL45、FAEL60, FH01
Primary DI / UDI-DI
06921348306682
Basic UDI-DI
69213483FH0103E4S
EMDN Code
H02030199 Linear staplers for videosurgery - other
Device Class
Class IIa
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

  • Sterile
  • Administering Medicine

Other properties (11)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No