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HILZO Esophageal Covered Stent (PTFE)

by BCM Co., Ltd. 33 variants

Ref EVP2012HC2

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08809423560120 Basic UDI-DI 08809423560120UDI-DIDate6 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809423560120 UDI-DI Date21 Jan 2026ListedStatusListed GUDID: in commercial distribution

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

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
HILZO Esophageal Covered Stent (PTFE) EUDAMED
HILZO Esophageal stents GUDID
Generic Name
Polymer-metal oesophageal stent
Model / Reference
EVP2012HC2
Primary DI / UDI-DI
08809423560120
Basic UDI-DI
B-08809423560120
FDA Product Code
ESW
EMDN Code
P050101 Gastro-esophageal reflux correction prostheses
GMDN Term
Polymer-metal oesophageal stent
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.3610
Market of Registration
Türkiye
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

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

Other devices from Bcm Co., Ltd.

See all devices from Bcm Co., Ltd. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (16)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No