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Ferritin Rapid Quantitative Test(Chemiluminescence Immunoassay)

by Xiamen Biotime Biotechnology Co., Ltd.

Ref BT0506603, BT0506604, BT0506601, BT0506602, BT2701, BT0506605

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE IVDD, withdrawn

Ended

Withdrawn

Date not published (CE IVDD)

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/IVDD NumberB-06933260207541 Basic UDI-DI Date24 Nov 2022RegisteredStatusWithdrawn No longer placed 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  • Withdrawn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European Union — CE/IVDD Withdrawn

Specification

EUDAMED

Trade Name
Ferritin Rapid Quantitative Test(Chemiluminescence Immunoassay)
Ferritin Rapid Quantitative Test
Device Name
Ferritin Rapid Quantitative Test (Fluorescence Immunoassay)
Model / Reference
BT0506603, BT0506604, BT0506601, BT0506602, BT2701, BT0506605
Primary DI / UDI-DI
06933260207541, 06933260207558, 06933260207527, 06933260207534, 06933260208562, 06933260207565
Basic UDI-DI
B-06933260207541, B-06933260207558, B-06933260207527, B-06933260207534, B-06933260208562, B-06933260207565
EMDN Code
W0102070102 Ferritin
Device Class
Class IVD General
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000012852
Authorised representative
Lotus NL B.V. NL-AR-000000121

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Properties

  • Reagent
  • Near-Patient Testing
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No