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Density Reagent

by Guangzhou LBP Medicine Science & Technology Co., Ltd. 2 variants

Ref BCP.L.000476Model 1) 12 tests/bottle; 2)100 tests/bottle

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 Number69485009LBP005MU Basic UDI-DI 06948500936235UDI-DIDate18 Dec 2024RegisteredStatusActive

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  • Withdrawn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
Density Reagent
Model / Reference
1) 12 tests/bottle, 2)100 tests/bottle, BCP.L.000476
Primary DI / UDI-DI
06948500936235
Basic UDI-DI
69485009LBP005MU
EMDN Code
W01030799 Histology / cytology reagents - other
Device Class
Class A
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000026786
Authorised representative
Kingsmead Service B.V. NL-AR-000002066

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Properties

  • Reagent
  • Professional Testing

Other properties (9)

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