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Anti-SS-B IgG CLIA Microparticles

EUDAMED

Class B (EU MDR)

Ref CMQ0908Model AutoLumo analyzerRef CMQ0910Ref CMQ0905Ref CMQ0903

by Autobio Diagnostics Co., Ltd.

Identity

Trade Name
Anti-SS-B IgG CLIA Microparticles EUDAMED
Model / Reference
AutoLumo analyzer EUDAMED
CMQ0908 EUDAMED
CMQ0910 EUDAMED
CMQ0905 EUDAMED
CMQ0903 EUDAMED

Identifiers

Primary DI / UDI-DI
06942359512602 EUDAMED
06942359512626 EUDAMED
06942359544887 EUDAMED
06942359544863 EUDAMED
Basic UDI-DI
697015090000307HD EUDAMED
EMDN Code
W0102100113 SS-B EUDAMED
W0102152211 STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY EUDAMED

Classification

Device Class
Class B EUDAMED
Market of Registration
Türkiye EUDAMED
Romania EUDAMED
France EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

Yes

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

Anti-SS-B IgG CLIA Microparticles by Autobio Diagnostics Co., Ltd. — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

Manufacturer
Autobio Diagnostics Co., Ltd.
EUDAMED SRN
CN-MF-000003348
Authorised Representative
QbD RepS BV BE-AR-000000040

Sources (4)

  • EUDAMED 5122864d-0fe2-4288-973a-65fdcf2fd143 61 fields · synced Jul 31, 2026
  • EUDAMED 3d02eed0-42cc-419e-af59-1cc48d8dd13b 61 fields · synced May 17, 2026
  • EUDAMED 9c40f03d-084e-49b3-82e5-0e1aba5c5063 61 fields · synced May 18, 2026
  • EUDAMED b800d7a8-1d79-444c-8668-df0b972d299c 61 fields · synced May 18, 2026