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Anti-SSA(Ro52) Antibody Chemiluminescent Immunoassay Kit

by Maccura Biotechnology Co., Ltd. 3 variants

Ref IM4415257, IM4410257, IM4411257, IM4414257Model IM4410257 IM4411257 IM4414257 IM4415257

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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69506174IM441257E2 Basic UDI-DI Date5 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Anti-SSA(Ro52) Antibody Chemiluminescent Immunoassay Kit
Model / Reference
IM4410257 IM4411257 IM4414257 IM4415257, IM4415257, IM4410257, IM4411257, IM4414257
Primary DI / UDI-DI
06950617403012, D-IM4415257K5, D-IM4410257J2, 06950617402985, D-IM4411257J9, D-IM4414257JW
Basic UDI-DI
69506174IM441257E2, B-IM4415257K5, B-IM4410257J2, B-IM4411257J9, B-IM4414257JW
Direct Marketing DI
06950617403012
06950617402985
EMDN Code
W0102100112 Ss-a
Device Class
Class B
Class IVD General
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000014618
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Maccura Biotechnology Co., Ltd.

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

Properties

  • Animal Tissues
  • Microbial Substances NoEUDAMEDYesEUDAMED
  • Reagent
  • Professional Testing

Other properties (7)

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