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Leukocyte Reduction Filters (sets)

EUDAMED

Class IIb (EU MDR)

Ref FBRC400-HE10Model FBPL01K-HE10, FBPL01K-HE10, FBPL01K-HX11, FBRC100-HE10, FBRC100-HE11, FBRC100-HX10, FBRC100-HX11, FBPL01K-HE11, FBRC200-HE10, FBRC200-HE11, FBRC200-HX10, FBRC200-HX11, FBRC400-HE10, FBRC400-HE11, FBRC400-HX10, FBRC400-HX11, FBRC450-HE10, FBRC450-HE11

by Guangzhou DaJi Medical Science and Technology Co., Ltd.

Identity

Device Name
Leukocyte Reduction Filters (sets) EUDAMED
Model / Reference
FBPL01K-HE10, FBPL01K-HE10, FBPL01K-HX11, FBRC100-HE10, FBRC100-HE11, FBRC100-HX10, FBRC100-HX11, FBPL01K-HE11, FBRC200-HE10, FBRC200-HE11, FBRC200-HX10, FBRC200-HX11, FBRC400-HE10, FBRC400-HE11, FBRC400-HX10, FBRC400-HX11, FBRC450-HE10, FBRC450-HE11 EUDAMED
FBRC400-HE10 EUDAMED

Identifiers

Primary DI / UDI-DI
06971942261054 EUDAMED
Basic UDI-DI
697194226FBGRL EUDAMED
EMDN Code
B02010201 LABORATORY ERYTHROCYTES (RBC) LEUKOREDUCTION FILTERS EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
Germany 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

Leukocyte Reduction Filters (sets) by Guangzhou DaJi Medical Science and Technology Co., Ltd. — Class IIb — MDR — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Guangzhou DaJi Medical Science and Technology Co., Ltd.
EUDAMED SRN
CN-MF-000035091
Authorised Representative
Share info GmbH DE-AR-000005132

Sources (1)

  • EUDAMED e6d65c85-cbf5-4921-af8d-c62681af7e22 61 fields · synced Oct 7, 2026