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Library Prep Consumables(for Library Construction)

by Sikun Life Science Co., Ltd. 11 variants

Ref HC0002Model 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

Active European Union

CE IVDR

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697560818model06FK Basic UDI-DI 06975608185203UDI-DIDate28 Aug 2026RegisteredStatusActive

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  • Withdrawn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/IVDR Active

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, HC0002
Primary DI / UDI-DI
06975608185203
Basic UDI-DI
697560818model06FK
EMDN Code
W02050115 DNA synthesizers
Device Class
Class A
EU market of registration
Belgium

Manufacturer details

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

Other devices from Sikun Life Science Co., Ltd.

See all devices from Sikun Life Science Co., Ltd. →

Properties

  • Sterile
  • Professional Testing
  • New Device

Other properties (8)

  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No