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OCI-BD-S-A(a1-b1)

EUDAMED

Class IIa (EU MDR)

Ref OCI-BD-S-A(a1-b1)Model Hemodialysis Blood Tubing Sets

by Chengdu Oci Medical Devices Co., Ltd.

Identity

Trade Name
OCI-BD-S-A(a1-b1) EUDAMED
Device Name
Hemodialysis Blood Tubing Sets EUDAMED
Model / Reference
Hemodialysis Blood Tubing Sets EUDAMED
OCI-BD-S-A(a1-b1) EUDAMED

Identifiers

Primary DI / UDI-DI
06937909326075 EUDAMED
06937909303236 EUDAMED
Basic UDI-DI
69379093HBTS002YD EUDAMED
69379093HBTS001YB EUDAMED
EMDN Code
F020199 ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION - OTHER EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Netherlands 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

OCI-BD-S-A(a1-b1) by Chengdu Oci Medical Devices 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-000009700
Authorised Representative
Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551

Sources (2)

  • EUDAMED 99ec6c99-e172-4955-8c8f-b71bb617a29a 61 fields · synced Oct 6, 2026
  • EUDAMED 1940a249-764e-43f6-98e8-12e19a6af020 61 fields · synced May 19, 2026