010112-602008

by Jiangsu Kangle Medical Device Co., Ltd.

Ref 010112-602008Model KL-8019-CT-200-Mark B

Active European Union

CE MDR

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number697039294010112-6020089F Basic UDI-DI 06937137112525UDI-DI	Date27 Mar 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Withdrawn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/MDR Active

Specification

EUDAMED

Model / Reference: KL-8019-CT-200-Mark B, 010112-602008

Primary DI / UDI-DI: 06937137112525
Basic UDI-DI: 697039294010112-6020089F
EMDN Code: A02010401 Syringes for contrast media injector, single-use

Device Class: Class IIa
EU market of registration: Romania

Manufacturer details

EUDAMED SRN: CN-MF-000041147
Authorised representative: HUMISS TRADING S. L. ES-AR-000040177

Other devices from Jiangsu Kangle Medical Device Co., Ltd.

010203-701108

Class IIa
010204-702207

Class IIa
010215

Class IIa
010213-701207

Class IIa
0831310

Class IIa
0841109

Class IIa

See all devices from Jiangsu Kangle Medical Device Co., Ltd. →

Properties

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