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bluesail surgical

by Changzhou Tongchuang Medical Instrument Technology Co., Ltd. China EUDAMED

Ref TCZN-60E

EMDN H020201010102

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06954790922650 Basic UDI-DIDate22 Nov 2025RegisteredStatusActive

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 25 Oct 2026

Device Name
Disposable Endo Cutter stapler - Cartridges
Model / Reference
TCZN-60E
Primary DI / UDI-DI
06954790922650
Basic UDI-DI
B-06954790922650
EMDN Code
H020201010102 Single patient straight linear staplers without blade for open surgery
Device Class
Class IIb
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
CN-MF-000028788
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Changzhou Tongchuang Medical Instrument Technology Co., Ltd.

See all devices from Changzhou Tongchuang Medical Instrument Technology Co., Ltd. →

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 a5270578-5bfd-43d7-8164-dc35f4bc445e 61 fields · synced 25 Oct 2026