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Artron Hepatitis B Virus Surface Antigen (HBsAg) Test

EUDAMED

Class IVD Annex II List A (EU MDR)

Ref A02-01-222Model CassetteRef A02-01-322P25

by Artron Laboratories Inc.

Identity

Trade Name
Artron Hepatitis B Virus Surface Antigen (HBsAg) Test EUDAMED
Artron Hepatitis B Surface Antigen (HBsAg) Test EUDAMED
Device Name
Hepatitis B Virus Surface Antigen (HBsAg) Test EUDAMED
Hepatitis B Surface Antigen (HBsAg) Test EUDAMED
Model / Reference
Cassette EUDAMED
A02-01-222 EUDAMED
A02-01-322P25 EUDAMED

Identifiers

Primary DI / UDI-DI
00628347560874 EUDAMED
00628347560881 EUDAMED
Basic UDI-DI
B-00628347560874 EUDAMED
62834756AL0201025Z EUDAMED
EMDN Code
W0105090201 HBSAG - RT & POC EUDAMED

Classification

Device Class
Class IVD Annex II List A EUDAMED
Class D EUDAMED
Market of Registration
Romania EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMEDEUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMEDEUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

Artron Hepatitis B Virus Surface Antigen (HBsAg) Test by Artron Laboratories Inc. — Class IVD Annex II List A — IVDR, IVDD — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Artron Laboratories Inc.
EUDAMED SRN
CA-MF-000028974
Authorised Representative
MedNet EC-REP GmbH DE-AR-000000002

Sources (2)

  • EUDAMED 26616f4f-2a2b-43f6-be62-95108bc24204 61 fields · synced Jul 11, 2026
  • EUDAMED 32779b20-ddfd-4fc7-848b-a4ab44c7d4d6 61 fields · synced Jul 11, 2026