Skip to content

Filtryzer B3

by Toray Industries, Inc.

Ref B3-1.0AModel B3-1.0A, B3-1.3A, B3-1.6A, B3-1.8A, B3-2.0A

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4960685002001000DS Basic UDI-DI 04960685104263UDI-DIDate2 Jul 2025RegisteredStatusActive

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  • Withdrawn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

Model / Reference
B3-1.0A, B3-1.3A, B3-1.6A, B3-1.8A, B3-2.0A
Primary DI / UDI-DI
04960685104263
Basic UDI-DI
4960685002001000DS
EMDN Code
F01060199 DIALYSERS - UFC < 18 ml/h/mmHg - OTHER
Device Class
Class IIb
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
JP-MF-000034536
Authorised representative
Toray International Italy S.r.l. IT-AR-000012629

Other devices from Toray Industries, Inc.

See all devices from Toray Industries, Inc. →

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