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Disposable Endoscopic Linear Cutter Stapler

by Fengh Medical Co., Ltd. 9 variants

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

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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69213483FH0103E4S Basic UDI-DI 06921348306699UDI-DIDate17 Aug 2026RegisteredStatusActive

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.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
FAES45、FAES60、FAEM45、FAEM60、FAEL45、FAEL60, FH01
Primary DI / UDI-DI
06921348306699
Basic UDI-DI
69213483FH0103E4S
EMDN Code
H02030199 Linear staplers for videosurgery - other
Device Class
Class IIa
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

  • 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