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Cleaning Solution

by Shenzhen Xilaiheng Medical Electronics Co., Ltd. 2 variants

Ref /Model BC02

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697520038BC2LD Basic UDI-DI 06975200383465UDI-DIDate18 Aug 2026RegisteredStatusActive EUDAMED: not on the EU market

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Cleaning Solution
Model / Reference
BC02, /
Primary DI / UDI-DI
06975200383465
Basic UDI-DI
697520038BC2LD
Direct Marketing DI
06975200383465
EMDN Code
W01019099 Clinical chemistry reagents - other
Device Class
Class A

Manufacturer details

EUDAMED SRN
CN-MF-000047090
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Shenzhen Xilaiheng Medical Electronics Co., Ltd.

Properties

  • Reagent

Other properties (10)

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