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Plasmaflo

by Asahi Kasei Medical Co., Ltd. 2 variants

Ref OP-05W(L)

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4537693PL-OP/0016B Basic UDI-DI 04537693150010UDI-DIDate29 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Plasmaflo OP
Model / Reference
OP-05W(L)
Primary DI / UDI-DI
04537693150010
Basic UDI-DI
4537693PL-OP/0016B
EMDN Code
B030201 Plasmapheresis devices and kits
Device Class
Class IIb
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
JP-MF-000013951
Authorised representative
Asahi Kasei Medical Europe GmbH DE-AR-000012752

Other devices from Asahi Kasei Medical Co., Ltd.

See all devices from Asahi Kasei Medical Co., Ltd. →

Properties

  • 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