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Disposable Linear Cutter Stapler Reload Unit

by Wuxi Beien Surgery Device Co., Ltd. China EUDAMED

Ref 8038EModel BCA80

EMDN H0202010301

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06971767878031 Basic UDI-DIDate8 Apr 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Disposable Linear Cutter Staplers
Model / Reference
BCA80, 8038E
Primary DI / UDI-DI
06971767878031
Basic UDI-DI
B-06971767878031
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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED fe729011-24d6-4e35-abff-348e647173e9 61 fields · synced 23 Oct 2026