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Automated Workstation

by Suzhou Sym-Bio Lifescience Co., Ltd. China EUDAMED

Ref SY61-01Model Pre-NAT II

EMDN W02050106

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69510458INST_PreNATIISRW Basic UDI-DIDate8 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Automated Workstation
Model / Reference
Pre-NAT II, SY61-01
Primary DI / UDI-DI
06951045800053
Basic UDI-DI
69510458INST_PreNATIISRW
Direct Marketing DI
06951045800053
EMDN Code
W02050106 DNA genomic preparation devices
Device Class
Class A
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000012847
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
  • Surgical Instrument
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (1)

  • EUDAMED 71f83e3d-00fc-4e31-ab42-605966860bd5 61 fields · synced 22 Oct 2026