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bluesail surgical

by Changzhou Tongchuang Medical Instrument Technology Co., Ltd. 6 variants

Ref TCNX-45S

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06954790922490 Basic UDI-DI 06954790922490UDI-DIDate20 Nov 2025RegisteredStatusActive

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

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
Disposable Endo Cutter stapler
Model / Reference
TCNX-45S
Primary DI / UDI-DI
06954790922490
Basic UDI-DI
B-06954790922490
EMDN Code
H020301040102 Single patient straight linear staplers with blade for laparoscopy
Device Class
Class IIa
EU 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

  • Sterile

Other properties (10)

  • Implantable: No
  • 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