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PreludeSYNC EZ™

by Biosphere Medical SA 2 variants

Ref EZ-REG/AModel Vascular Compression Devices

Active European Union

CE MDD

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 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-00884450688359 Basic UDI-DI 00884450688359UDI-DIDate3 Nov 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  • Withdrawn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/MDD Active

Specification

EUDAMED

Device Name
PreludeSYNC Device Family
Model / Reference
Vascular Compression Devices, EZ-REG/A
Primary DI / UDI-DI
00884450688359
Basic UDI-DI
B-00884450688359
EMDN Code
W0202029085 Various hemostasis instruments - consumables
Device Class
Class I
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
FR-MF-000005250

Other devices from Biosphere Medical SA

See all devices from Biosphere Medical SA →

Properties

  • Sterile
  • Animal Tissues

Other properties (9)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No