← Back to catalogue

010112

EUDAMED

Class IIa (EU MDR)

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

by Jiangsu Kangle Medical Device Co., Ltd.

Identity

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

Identifiers

Primary DI / UDI-DI
06937137112488 EUDAMED
06937137112525 EUDAMED
Basic UDI-DI
697039294010112SB EUDAMED
697039294010112-6020089F 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

010112 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

Is this your device? Claim it to add documentation and request validation.

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 5af611b7-f0b6-4923-8c4d-5d4171e09f22 61 fields · synced Oct 6, 2026
  • EUDAMED 649f178d-3b3c-4cf0-9cef-7f0276884efa 61 fields · synced May 18, 2026