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Single Use Powered Endoscopic Linear Cutter Stapler

by Suzhou Frankenman Medical Equipment Co., Ltd China EUDAMED

Ref FP ELCB250Model FP ELCB50

EMDN H020301040202

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69338168FPELC1TX Basic UDI-DIDate13 Nov 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
FP ELCB50, FP ELCB250
Primary DI / UDI-DI
06933816809298
Basic UDI-DI
69338168FPELC1TX, 69338168FPELCBUX
EMDN Code
H020301040202 Single patient straight linear staplers without blade for laparoscopy
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000012943
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Suzhou Frankenman Medical Equipment Co., Ltd

See all devices from Suzhou Frankenman Medical Equipment Co., Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • 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

Sources (2)

  • EUDAMED 8f659c4c-8b04-4802-8de9-0620e179c7c4 61 fields · synced 25 Oct 2026
  • EUDAMED 06933816809298|69338168FPELCBUX 61 fields · synced 25 Oct 2026