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Disposable Plasma Apheresis Sets

by Haier Haematologi Chongqing Co., Ltd. China EUDAMED

Ref FLQ/B1G1C1P13Model FLQ/B1G1C1P13, FLQ/B1G1C1P3, FLQ/B1G1C1P15, FLQ/B1G1C1P14, FLQ/B1G1C1P1, FLQ/B1G1C1P12, FLQ/B1G1C1P11, FLQ/B1G1C1P2 EMDN B030101

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697461485A002F8 Basic UDI-DIDate4 Jan 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Disposable Plasma Apheresis Set - bottle
Model / Reference
FLQ/B1G1C1P13, FLQ/B1G1C1P3, FLQ/B1G1C1P15, FLQ/B1G1C1P14, FLQ/B1G1C1P1, FLQ/B1G1C1P12, FLQ/B1G1C1P11, FLQ/B1G1C1P2
Primary DI / UDI-DI
06974614855131
Basic UDI-DI
697461485A002F8
EMDN Code
B030101 Apheresis plasma collection devices
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000015706
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Haier Haematologi Chongqing Co., Ltd.

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 8e021b1b-193e-4764-9eef-ca4dbb56ef7f 61 fields · synced 22 Oct 2026