← Back to catalogue

Line Immuno Assay (LIA) for the Detection of Antinuclear Antibodies

EUDAMED

Class IVD General (EU MDR)

Ref MB00175Model ANA-9, 16 TestsRef MB00176Model ENA-7, 16 TestsRef MB00174Model ANA-13, 16 Tests

by HOB Biotech Group Corp., Ltd.

Identity

Trade Name
Line Immuno Assay (LIA) for the Detection of Antinuclear Antibodies EUDAMED
Device Name
Line Immuno Assay (LIA) for the Detection of Antinuclear Antibodies EUDAMED
Model / Reference
ANA-9, 16 Tests EUDAMED
MB00175 EUDAMED
ENA-7, 16 Tests EUDAMED
MB00176 EUDAMED
ANA-13, 16 Tests EUDAMED
MB00174 EUDAMED

Identifiers

Primary DI / UDI-DI
06924030400958 EUDAMED
06924030400965 EUDAMED
06924030400941 EUDAMED
Basic UDI-DI
B-06924030400958 EUDAMED
B-06924030400965 EUDAMED
B-06924030400941 EUDAMED
EMDN Code
W0102100101 ANA SCREENING EUDAMED
W0102100102 ENA SCREENING EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Türkiye EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

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

Line Immuno Assay (LIA) for the Detection of Antinuclear Antibodies by HOB Biotech Group Corp., Ltd. — Class IVD General — IVDD — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
HOB Biotech Group Corp., Ltd.
EUDAMED SRN
CN-MF-000023974
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (3)

  • EUDAMED 34b31dce-eaaf-43e0-a089-e828a2fe57b6 61 fields · synced Oct 6, 2026
  • EUDAMED a6d86aa8-7ca6-4fe0-8647-5a574d859d2c 61 fields · synced May 18, 2026
  • EUDAMED abc90878-eed1-47b1-960e-4fce7ff548b9 61 fields · synced May 18, 2026