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Multi-Use Tubing System Kit

EUDAMED

Class IIa (EU MDR)

Ref DRT-L202Model AGT1-I、AGT1-II、 AGT2、AGT2-I、AGT2-II、AGT2-III、BF2、BF2-I、AI、AII

by Shenzhen Boon Medical Supply Co., Ltd.

Identity

Trade Name
Multi-Use Tubing System Kit EUDAMED
Device Name
Multi-Use Tubing System Kit EUDAMED
Model / Reference
AGT1-I、AGT1-II、 AGT2、AGT2-I、AGT2-II、AGT2-III、BF2、BF2-I、AI、AII EUDAMED
DRT-L202 EUDAMED

Identifiers

Primary DI / UDI-DI
06938327901813 EUDAMED
Basic UDI-DI
69383279217XQ EUDAMED
EMDN Code
A02010401 SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
France 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

Yes

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Category: Angiography kit

Multi-Use Tubing System Kit by Shenzhen Boon Medical Supply 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
Shenzhen Boon Medical Supply Co., Ltd.
EUDAMED SRN
CN-MF-000018400
Authorised Representative
Wellkang Ltd XI-AR-000001836

Sources (1)

  • EUDAMED 7c85f575-fdea-4d8a-8352-3651e34e9076 61 fields · synced Jun 19, 2026