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010213-701208

EUDAMED

Class IIa (EU MDR)

Ref 010213-701208Model KL-8019-CT-200/200-Mark B

by Jiangsu Kangle Medical Device Co., Ltd.

Identity

Model / Reference
KL-8019-CT-200/200-Mark B EUDAMED
010213-701208 EUDAMED

Identifiers

Primary DI / UDI-DI
06937137112594 EUDAMED
Basic UDI-DI
697039294010213-701208BF EUDAMED
EMDN Code
A02010401 SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Romania EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Category: Angiography kit

010213-701208 by Jiangsu Kangle Medical Device Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Angiography kit.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Jiangsu Kangle Medical Device Co., Ltd.
EUDAMED SRN
CN-MF-000041147
Authorised Representative
HUMISS TRADING S. L. ES-AR-000040177

Sources (1)

  • EUDAMED f03dc002-3fdd-44d2-b35d-d0b4de0aea4d 61 fields · synced Jul 15, 2026