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Disposable Linear Cutter Stapler Reload Unit

by Wuxi Beien Surgery Device Co., Ltd. EUDAMED

Active European Union

Ref 10045EModel GCA100

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06971767871032 Basic UDI-DIDate8 Apr 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD 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

Device Name
Disposable Linear Cutter Staplers
Model / Reference
GCA100, 10045E
Primary DI / UDI-DI
06971767871032
Basic UDI-DI
B-06971767871032
EMDN Code
H0202010301 Single-patient linear suture cartdriges with blade for open surgery
Device Class
Class IIb
Market of Registration
Northern Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000017684
Authorised representative
Prolinx GmbH DE-AR-000005129

Other devices from Wuxi Beien Surgery Device Co., Ltd.

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Properties

  • Sterile
  • Implantable

Other properties (9)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No