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Cn-Coagwasher

by Sysmex Corporation 3 variants

Ref AG888161

Cn-Coagwasher (AG888161) is a Class A device made by Sysmex Corporation, registered in EUDAMED on 5 Oct 2026 (Basic UDI-DI 4987562CN-COAGWASHER7C), active as of 23 Oct 2026.

Active European Union

CE IVDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number4987562CN-COAGWASHER7C Basic UDI-DI 14987562528032UDI-DIDate5 Oct 2026RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Model / reference
AG888161
Primary DI / UDI-DI
14987562528032
Basic UDI-DI
4987562CN-COAGWASHER7C
EMDN code
W0103020999 Auxiliary reagents (haemostasis) - other
Device class
Class A
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
JP-MF-000014037
Authorised representative
Sysmex Europe SE DE-AR-000022333

Similar devices in this category

Other devices filed under AUXILIARY REAGENTS (HAEMOSTASIS) - OTHER.

Other devices from Sysmex Corporation

See all devices from Sysmex Corporation →

Properties

  • Reagent
  • Professional testing
Other properties (11, all answered No)