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SARS-CoV-2 IgG Antibody Test Kit (Chemiluminescence Immunoassay)

EUDAMED

Class IVD General (EU MDR)

Ref S2054E-100Ref S2054E-50

by Sansure Biotech Inc.

Identity

Device Name
SARS-CoV-2 IgG Antibody Test Kit (Chemiluminescence Immunoassay) EUDAMED
Model / Reference
S2054E-100 EUDAMED
S2054E-50 EUDAMED

Identifiers

Primary DI / UDI-DI
06955792740082 EUDAMED
06955792740068 EUDAMED
Basic UDI-DI
B-06955792740082 EUDAMED
B-06955792740068 EUDAMED
EMDN Code
W0102010105 IMMUNOGLOBULIN G EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
France EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

Yes

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

Category: Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD

SARS-CoV-2 IgG Antibody Test Kit (Chemiluminescence Immunoassay) by Sansure Biotech Inc. — Class IVD General — IVDD — listed in EUDAMED

Similar devices

Also classified as Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Sansure Biotech Inc.
EUDAMED SRN
CN-MF-000011392
Authorised Representative
Obelis s.a. BE-AR-000000106

Sources (2)

  • EUDAMED 8825a150-3afb-4402-a7cc-929ea1cafdd5 61 fields · synced Jul 23, 2026
  • EUDAMED 250a671d-b351-46d1-bc4c-353fd647cb2c 61 fields · synced May 18, 2026