bluesail surgical

by Changzhou Tongchuang Medical Instrument Technology Co., Ltd. 49 variants

Ref TCZNXKO-60C, TCZNXKO-45B, TCZN-60F, TCZNZO-60J, TCZNXO-60E, TCZNXKO-30I, TCZNZO-60B, TCZNXKO-30C, TCZNXK-45C, TCZNXK-30E, TCZNXKO-60F, TCZN-60C, TCZN-45E, TCZNXO-30I, TCZNXK-30I, TCZNXK-45E, TCZNXK-30H, TCZN-60A, TCZNXKO-45J, TCZNXO-45F, TCZN-45F, TCZNX-30H, TCZNX-45E, TCZNXK-60C, TCZN-45D, TCZNZO-30C, TCZNX-30C, TCZNX-45I, TCZNZO-30I, TCZNZO-30E, TCZNX-30E, TCNX-60S, TCZNZO-45J, TCZNXO-60C, TCZNX-60J, TCZNX-45H, TCZNX-60F, TCZNXK-45I, TCNQ-M, TCZNZO-60H, TCZNXO-60B, TCZNXO-30B, TCZNXO-60I, TCZNXK-60J, TCZNXK-45B, TCZNXKO-60I, TCZNXK-60F, TCZNXKO-30H, TCZNXO-45C, TCNQ-L, TCZN-60B

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDD	NumberB-06954790918226 Basic UDI-DI	Date22 Nov 2025Registered	StatusActive

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

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device Name: Disposable Endo Cutter stapler - Cartridges
Disposable Endo Cutter stapler
Model / Reference: TCZNXKO-60C, TCZNXKO-45B, TCZN-60F, TCZNZO-60J, TCZNXO-60E, TCZNXKO-30I, TCZNZO-60B, TCZNXKO-30C, TCZNXK-45C, TCZNXK-30E, TCZNXKO-60F, TCZN-60C, TCZN-45E, TCZNXO-30I, TCZNXK-30I, TCZNXK-45E, TCZNXK-30H, TCZN-60A, TCZNXKO-45J, TCZNXO-45F, TCZN-45F, TCZNX-30H, TCZNX-45E, TCZNXK-60C, TCZN-45D, TCZNZO-30C, TCZNX-30C, TCZNX-45I, TCZNZO-30I, TCZNZO-30E, TCZNX-30E, TCNX-60S, TCZNZO-45J, TCZNXO-60C, TCZNX-60J, TCZNX-45H, TCZNX-60F, TCZNXK-45I, TCNQ-M, TCZNZO-60H, TCZNXO-60B, TCZNXO-30B, TCZNXO-60I, TCZNXK-60J, TCZNXK-45B, TCZNXKO-60I, TCZNXK-60F, TCZNXKO-30H, TCZNXO-45C, TCNQ-L, TCZN-60B

Primary DI / UDI-DI: 06954790918226, 06954790917656, 06954790922667, 06954790916789, 06954790917984, 06954790917328, 06954790916703, 06954790917267, 06954790917465, 06954790917083, 06954790918257, 06954790922636, 06954790922599, 06954790917229, 06954790917120, 06954790917489, 06954790917113, 06954790922612, 06954790917731, 06954790917595, 06954790922605, 06954790916963, 06954790917380, 06954790917861, 06954790922582, 06954790915768, 06954790916918, 06954790917427, 06954790915829, 06954790915782, 06954790916932, 06954790922520, 06954790916383, 06954790917960, 06954790917830, 06954790917410, 06954790917793, 06954790917526, 06954790915515, 06954790916765, 06954790917953, 06954790917151, 06954790918189, 06954790917939, 06954790917458, 06954790918288, 06954790917892, 06954790917311, 06954790917564, 06954790915508, 06954790922629
Basic UDI-DI: B-06954790918226, B-06954790917656, B-06954790922667, B-06954790916789, B-06954790917984, B-06954790917328, B-06954790916703, B-06954790917267, B-06954790917465, B-06954790917083, B-06954790918257, B-06954790922636, B-06954790922599, B-06954790917229, B-06954790917120, B-06954790917489, B-06954790917113, B-06954790922612, B-06954790917731, B-06954790917595, B-06954790922605, B-06954790916963, B-06954790917380, B-06954790917861, B-06954790922582, B-06954790915768, B-06954790916918, B-06954790917427, B-06954790915829, B-06954790915782, B-06954790916932, B-06954790922520, B-06954790916383, B-06954790917960, B-06954790917830, B-06954790917410, B-06954790917793, B-06954790917526, B-06954790915515, B-06954790916765, B-06954790917953, B-06954790917151, B-06954790918189, B-06954790917939, B-06954790917458, B-06954790918288, B-06954790917892, B-06954790917311, B-06954790917564, B-06954790915508, B-06954790922629
EMDN Code: H020301040102, H020201010102

Device Class: Class IIb
Class IIa
EU market of registration: Germany
Romania

Manufacturer details

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

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

Properties

Sterile
Implantable YesEUDAMEDNoEUDAMED

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