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Hemodialysis bloodline

EUDAMED

Class IIa (EU MDR)

Ref CK.BPC-012Model DEHP

by Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.

Identity

Trade Name
Hemodialysis bloodline EUDAMED
Device Name
Hemodialysis bloodline EUDAMED
Model / Reference
DEHP EUDAMED
CK.BPC-012 EUDAMED

Identifiers

Primary DI / UDI-DI
06939348145699 EUDAMED
Basic UDI-DI
6939348121040062a010101B8 EUDAMED
EMDN Code
C03010199 EXTRACORPOREAL CIRCULATION KITS - OTHER EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Bulgaria 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

Hemodialysis bloodline by Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
CN-MF-000016493
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (1)

  • EUDAMED d7b9456c-5fac-44b5-a94f-04d0d9f9c90d 61 fields · synced Oct 7, 2026