Skip to content

Rapid Test Reader

by KAIWOOD Technology Co., Ltd. EUDAMED

Active European Union

Ref CHR-636, CHR-631Model CHR-631 and CHR-636

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number471987187CHR63XYUA Basic UDI-DIDate4 Feb 2026RegisteredStatusActive

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  • Withdrawn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
CHR-631 and CHR-636, CHR-636, CHR-631
Primary DI / UDI-DI
04719871870242, 04719871870105
Basic UDI-DI
471987187CHR63XYUA
Direct Marketing DI
04719871870242
04719871870105
EMDN Code
W0201069099 Various rapid test chemistry / immunochemistry instruments - other
Device Class
Class A
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
TW-MF-000043631
Authorised representative
Obelis s.a. BE-AR-000000106

Properties

  • Professional Testing
  • Surgical Instrument

Other properties (9)

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