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Sterile Leukocyte Reduction Filters

EUDAMED

Class IIb (EU MDR)

Ref ZBK-Q-450SGRef ZBK-RF-200BRef ZBK-RF-300SRRef ZBK-H-450SGRef ZBK-Q-500B2Ref ZBK-H-500B1Ref ZBK-Q-500SRef ZBK-H-450SRef ZBK-Q-450SRRef ZBK-H-500SRRef ZBK-H-450SRRef ZBK-RF-200SRRef ZBK-Q-500SGRef ZBK-Q-500B1Ref ZBK-RF-400SRRef ZBK-H-500S

by Shandong Zhongbaokang Medical Implements Co., Ltd.

Identity

Device Name
Sterile Leukocyte Reduction Filters EUDAMED
Sterile Leukocyte Reduction Filters for Single Use EUDAMED
Model / Reference
ZBK-Q-450SG EUDAMED
ZBK-RF-200B EUDAMED
ZBK-RF-300SR EUDAMED
ZBK-H-450SG EUDAMED
ZBK-Q-500B2 EUDAMED
ZBK-H-500B1 EUDAMED
ZBK-Q-500S EUDAMED
ZBK-H-450S EUDAMED
ZBK-Q-450SR EUDAMED
ZBK-H-500SR EUDAMED
ZBK-H-450SR EUDAMED
ZBK-RF-200SR EUDAMED
ZBK-Q-500SG EUDAMED
ZBK-Q-500B1 EUDAMED
ZBK-RF-400SR EUDAMED
ZBK-H-500S EUDAMED

Identifiers

Primary DI / UDI-DI
06970494389773 EUDAMED
06970494389964 EUDAMED
06970494389834 EUDAMED
06970494389766 EUDAMED
06970494389988 EUDAMED
06970494389896 EUDAMED
06970494389735 EUDAMED
06970494389803 EUDAMED
06970494389797 EUDAMED
06970494389704 EUDAMED
06970494389780 EUDAMED
06970494389841 EUDAMED
06970494389698 EUDAMED
06970494389902 EUDAMED
06970494389827 EUDAMED
06970494389728 EUDAMED
Basic UDI-DI
697049438ZBKQB015C EUDAMED
697049438ZBKQB025E EUDAMED
EMDN Code
B02010299 LABORATORY LEUKOREDUCTION FILTERS - OTHER EUDAMED
B02010201 LABORATORY ERYTHROCYTES (RBC) LEUKOREDUCTION FILTERS EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
Hungary EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

Yes

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

Sterile Leukocyte Reduction Filters by Shandong Zhongbaokang Medical Implements Co., Ltd. — Class IIb — 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

Manufacturer
Shandong Zhongbaokang Medical Implements Co., Ltd.
EUDAMED SRN
CN-MF-000013907
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (16)

  • EUDAMED 03b26fe8-5c77-41a4-90b8-6a997c53910c 61 fields · synced Oct 7, 2026
  • EUDAMED e7d9abe8-2b36-4c79-b7f9-5ab9d9553051 61 fields · synced May 16, 2026
  • EUDAMED e962c74b-30e3-4fcb-bbd8-10db40d80ab7 61 fields · synced May 16, 2026
  • EUDAMED 660863a1-647e-4f1b-a729-23a16ea724f4 61 fields · synced May 17, 2026
  • EUDAMED 3e3b9c22-b95a-4e4a-b106-bd99e6e4c681 61 fields · synced May 17, 2026
  • EUDAMED 406319d8-40b0-4f55-842a-30e53a1a5622 61 fields · synced May 17, 2026
  • EUDAMED 0ab53551-1392-42e3-bdb7-1b23de427038 61 fields · synced May 17, 2026
  • EUDAMED bdf4f024-05ff-4ce9-85e2-7aa093440774 61 fields · synced May 17, 2026
  • EUDAMED ab251b63-d3da-4dcc-82e6-cfd05540708d 61 fields · synced May 17, 2026
  • EUDAMED 40da767a-2b5d-4ef3-a4ac-6f70b4c2cd7d 61 fields · synced May 17, 2026
  • EUDAMED 9b9421a5-229e-46b1-af88-60d266e07e74 61 fields · synced May 18, 2026
  • EUDAMED 7cd34bad-b4b7-4f2f-89d5-4091ea7aa5ea 61 fields · synced May 18, 2026
  • EUDAMED b222b620-e973-4863-a58c-041e08f8f890 61 fields · synced May 18, 2026
  • EUDAMED adaf6c3b-df62-4108-8185-53e1d382902d 61 fields · synced May 18, 2026
  • EUDAMED 75343685-9829-4a3b-bb77-722a770b5391 61 fields · synced May 18, 2026
  • EUDAMED 81ba264a-431b-4118-94d7-d328fdc6b433 61 fields · synced May 19, 2026