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Synergo® System

by Medical Enterprises Europe B.V. Netherlands EUDAMED

Ref SB-TS 101.3Model SB-TS 101.3

EMDN Z12169080

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-07290010121045 Basic UDI-DIDate18 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Synergo® System SB-TS 101.3
Model / Reference
SB-TS 101.3
Primary DI / UDI-DI
07290010121045
Basic UDI-DI
B-07290010121045
EMDN Code
Z12169080 Various instruments for urology - hardware accessories
Device Class
Class IIb
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000019133

Other devices from Medical Enterprises Europe B.V.

Properties & raw data

Show properties, registry sources and raw records
  • Administering Medicine
  • Measuring Function
Other properties (9)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED f802a571-f7fb-40c4-870d-e6f0de1a8566 61 fields · synced 24 Oct 2026