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Urology

by SYNDEO Medical

Ref SYN-URO01-001Model URO 01

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5065021834SYNPP028ZM Basic UDI-DI 05065021834282UDI-DIDate14 Oct 2024RegisteredStatusActive

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  • Withdrawn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
URO (Urology)
Model / Reference
URO 01, SYN-URO01-001
Primary DI / UDI-DI
05065021834282
Basic UDI-DI
5065021834SYNPP028ZM
EMDN Code
U0399 Devices for urinary tract dilation - other
Device Class
Class I
Medical Purpose
Supports surgeries of the urinary system, offering sterile tools for urological interventions.

Manufacturer details

EUDAMED SRN
BE-PR-000044136

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Properties

  • Sterile