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010205

EUDAMED

Class IIa (EU MDR)

Ref 010205Model KL-8019-CT-200/200-Mark ARef 010205-702108

by Jiangsu Kangle Medical Device Co., Ltd.

Identity

Model / Reference
KL-8019-CT-200/200-Mark A EUDAMED
010205 EUDAMED
010205-702108 EUDAMED

Identifiers

Primary DI / UDI-DI
06937137112228 EUDAMED
06937137112440 EUDAMED
Basic UDI-DI
697039294010205SK EUDAMED
697039294010205-702108BY 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

010205 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 (2)

  • EUDAMED eea08748-04a7-477d-993b-61d2ca3bb3e3 61 fields · synced Jul 27, 2026
  • EUDAMED 1580e6de-205b-4315-8cc1-bea1adfd2362 61 fields · synced May 18, 2026