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Mycoplasma Pneumoniae IgG Antibody Chemiluminescent Immunoassay Kit

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref IM4403040, IM4402040, IM4411040, IM4406040, IM4415040, IM4407040, IM4414040Model IM4410040 IM4411040 IM4414040 IM4415040

EMDN W0105010899

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-IM4403040HH Basic UDI-DIDate22 May 2022RegisteredStatusActive
European UnionCE/IVDD NumberB-IM4403040HH Basic UDI-DIDate22 May 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR, CE/IVDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Mycoplasma Pneumoniae IgG Antibody Chemiluminescent Immunoassay Kit
Model / Reference
IM4403040, IM4402040, IM4410040 IM4411040 IM4414040 IM4415040, IM4411040, IM4406040, IM4415040, IM4407040, IM4414040
Primary DI / UDI-DI
D-IM4403040HH, D-IM4402040HA, 06950617416760, D-IM4406040J6, 06950617416524, D-IM4415040JA, D-IM4407040JD, 06950617416487
Basic UDI-DI
B-IM4403040HH, B-IM4402040HA, 69506174IM441040D7, B-IM4406040J6, B-IM4415040JA, B-IM4407040JD
Direct Marketing DI
06950617416760
06950617416524
06950617416487
EMDN Code
W0105010899, W0105010802
Device Class
Class IVD General
Class B
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000014618
Authorised representative
Humiss International B.V. NL-AR-000001490

Other devices from Maccura Biotechnology Co., Ltd.

See all devices from Maccura Biotechnology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (8)

  • EUDAMED 319beb91-6f5c-4c02-842a-ad6834c621e4 61 fields · synced 22 Oct 2026
  • EUDAMED b53d969b-87f3-40a1-b6b4-ca6171fbd8c4 61 fields · synced 16 May 2026
  • EUDAMED 603eec78-8b2f-49c6-90e3-bf70965186ec 61 fields · synced 16 May 2026
  • EUDAMED 10644457-9c72-4a6f-909b-d28bc6ddf370 61 fields · synced 16 May 2026
  • EUDAMED c6f0c898-7342-41ac-a188-2e8e15d41e7a 61 fields · synced 17 May 2026
  • EUDAMED c4f13e5a-9ae5-4cb8-864f-d8bc2cf6bec6 61 fields · synced 17 May 2026
  • EUDAMED d1e26a89-3913-41e2-8033-d2d46ef75e4a 61 fields · synced 18 May 2026
  • EUDAMED d56d87f5-c5d3-4e46-8c4f-613b7a1499b1 61 fields · synced 18 May 2026