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Reaction sample well

by BioTeke Corporation（Wuxi）Co., Ltd China EUDAMED

Ref BTK-E02-B48-25-00Model BTK-8-B10-10-00, BTK-8-B8-10-00, BTK-8-B4-10-00, BTK-8-B4-20-00, BTK-E04-B1-20-00, BTK-E04-B1-25-00, BTK-E04-B1-30-00, BTK-E04-B1-40-00, BTK-E02-B48-20-00, BTK-E02-B48-25-00" EMDN W0599

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697454156014L4 Basic UDI-DIDate15 May 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  • Withdrawn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 · synced 24 Oct 2026

Device Name
Reaction sample well
Model / Reference
BTK-8-B10-10-00, BTK-8-B8-10-00, BTK-8-B4-10-00, BTK-8-B4-20-00, BTK-E04-B1-20-00, BTK-E04-B1-25-00, BTK-E04-B1-30-00, BTK-E04-B1-40-00, BTK-E02-B48-20-00, BTK-E02-B48-25-00", BTK-E02-B48-25-00
Primary DI / UDI-DI
06974541565356
Basic UDI-DI
697454156014L4
EMDN Code
W0599 IVD general use consumable devices - other
Device Class
Class A
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000007517
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Bioteke Corporation (Wuxi) Co., Ltd.

See all devices from Bioteke Corporation (Wuxi) Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 06974541565356|697454156014L4 61 fields · synced 24 Oct 2026