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Tycheseal™

by Beijing Percutek Therapeutics Inc. China EUDAMED

Ref PTCW4032210Model PTCW

EMDN P070401010102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06957485023861 Basic UDI-DIDate23 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

IcelandNorwaySwedenFinlandFinlandNorwaySwedenFinlandFinlandNorwaySwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceLiechtensteinAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalyTürkiyeTürkiyeSpainSpainCroatiaGreeceTürkiyeTürkiyeTürkiyeTürkiyeMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

EU market availability

Available in 32 countries, as listed in EUDAMED:

  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greecesince 28 Feb 2024
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Liechtenstein
  • Lithuania
  • Luxembourg
  • Malta
  • Netherlands
  • Northern Ireland
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • Türkiye

Last checked 23 Oct 2026.

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Tycheseal™ Thoracic stent graft system
Model / Reference
PTCW, PTCW4032210
Primary DI / UDI-DI
06957485023861
Basic UDI-DI
B-06957485023861
EMDN Code
P070401010102 Dacron vascular endoprostheses, straight - thoracic
Device Class
Class III
Market of Registration
Greece

Manufacturer details

EUDAMED SRN
CN-MF-000013927
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Beijing Percutek Therapeutics Inc.

See all devices from Beijing Percutek Therapeutics Inc. →

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 (1)

  • EUDAMED c912c279-912e-4d01-a347-12e9e12bcd56 61 fields · synced 24 Oct 2026