Leukocyte Reduction Filters (sets)

EUDAMED

Class IIb (EU MDR)

Ref FSRC100-HE11Model FSPL01K, FSRC100, FSRC200, FSRC300, FSRC450,

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

Identity

Device Name: Leukocyte Reduction Filters (sets) EUDAMED
Model / Reference: FSPL01K, FSRC100, FSRC200, FSRC300, FSRC450, EUDAMED
FSRC100-HE11 EUDAMED

Identifiers

Primary DI / UDI-DI: 06971942261184 EUDAMED
Basic UDI-DI: 697194226FS3G EUDAMED
EMDN Code: B02010101 BED-SIDE ERYTHROCYTES (RBC) LEUKOREDUCTION FILTERS (WITH OR WITHOUT INFUSION CONTROLLER) 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 — 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	697194226FS3G	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 9dba9a47-225d-42e3-81bd-30bd33e0a762 61 fields · synced Jun 18, 2026