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Cleaning Solution

by BotuAImaging Technology Co., Ltd. EUDAMED

Active European Union

Ref 009Model Composite Type

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697626387CM001HJ Basic UDI-DIDate30 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • 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
Composite Type, 009
Primary DI / UDI-DI
06976263872088
Basic UDI-DI
697626387CM001HJ
EMDN Code
W0599 IVD general use consumable devices - other
Device Class
Class A
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
CN-MF-000035048
Authorised representative
Kingsmead Service B.V. NL-AR-000002066

Other devices from BotuAImaging Technology Co., Ltd.

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Properties

  • Professional Testing

Other properties (10)

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