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HILZO Esophageal Covered Stent (PTFE) with Nylon Suture

by BCM Co., Ltd. EUDAMED

Active European Union

Ref EVP2811AC1

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08800026608783 Basic UDI-DIDate6 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

No EU certificate is linked to this device in EUDAMED.

Specification

EUDAMED

Model / Reference
EVP2811AC1
Primary DI / UDI-DI
08800026608783
Basic UDI-DI
B-08800026608783
EMDN Code
P050101 Gastro-esophageal reflux correction prostheses
Device Class
Class IIb
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
KR-MF-000017292
Authorised representative
Emergo Europe B.V. NL-AR-000000116

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Properties

  • Sterile
  • Implantable

Other properties (11)

  • 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