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PEBBLE qcLAMP Platform

by Biopix DNA Technology S.A. EUDAMED

Active European Union

Ref 000057

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number5210166000057M3 Basic UDI-DIDate25 May 2023RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Model / Reference
000057
Primary DI / UDI-DI
05210166000027
Basic UDI-DI
5210166000057M3
Direct Marketing DI
05210166000027
EMDN Code
W02050199 Nucleic acid testing instruments except micro-arrays - other
Device Class
Class A
Market of Registration
Greece

Manufacturer details

EUDAMED SRN
GR-MF-000033590

Properties

  • Near-Patient Testing
  • Professional Testing
  • Surgical Instrument

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • New Device: No