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Library Prep Consumables(for Library Construction)

by Sikun Life Science Co., Ltd. EUDAMED

Active European Union

Ref HC0012Model Full-Skirted PCR Plate, Full-Skirted PCR Plate, Round Deep Well Plate, Squarel Deep Well Plate, 7#Tip, 8#Tip, SIKUN Waste Container, Semi-Skirted PCR Plate, Aluminum Sealing Film, Strip Holder, Reagent Reservoir, PCR Sealing Mat

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697560818model06FK Basic UDI-DIDate28 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
Full-Skirted PCR Plate, Round Deep Well Plate, Squarel Deep Well Plate, 7#Tip, 8#Tip, SIKUN Waste Container, Semi-Skirted PCR Plate, Aluminum Sealing Film, Strip Holder, Reagent Reservoir, PCR Sealing Mat, HC0012
Primary DI / UDI-DI
06975608185265
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
CN-MF-000047921
Authorised representative
Obelis s.a. BE-AR-000000106

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