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Nucleic Acid Extraction Kit

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

Ref SY609Model 48 tests

EMDN W0105900101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69510458PCR_Extraction6L Basic UDI-DIDate6 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
Nucleic Acid Extraction Kit
Model / Reference
48 tests, SY609
Primary DI / UDI-DI
06951045820020
Basic UDI-DI
69510458PCR_Extraction6L
EMDN Code
W0105900101 Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus
Device Class
Class A
Market of Registration
Netherlands

Manufacturer details

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

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Properties & raw data

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

Sources (1)

  • EUDAMED 11d76edd-524e-4fc4-95a7-ce755310e73e 61 fields · synced 22 Oct 2026