Leukocyte Reduction Filters (sets)

EUDAMED

Class IIb (EU MDR)

Ref FBRC100-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
FBRC100-HE10 EUDAMED

Identifiers

Primary DI / UDI-DI: 06971942260750 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

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

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

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	697194226FBGRL	Class IIb	Active

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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 50f7bfca-4e06-4012-bd72-06d50ec3d8f3 61 fields · synced Oct 7, 2026