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Determine

EUDAMED

Class IVD General (EU MDR)

Ref 7D2443Model Determine Syphilis TPRef 7D2253Model Determine HIV ControlsRef 7D2846

by Abbott Diagnostics Medical Co., Ltd.

Identity

Trade Name
Determine EUDAMED
Device Name
Determine Syphilis TP EUDAMED
Determine HIV Controls EUDAMED
Determine HIV Early Detect EUDAMED
Model / Reference
Determine Syphilis TP EUDAMED
7D2443 EUDAMED
Determine HIV Controls EUDAMED
7D2253 EUDAMED
7D2846 EUDAMED

Identifiers

Primary DI / UDI-DI
04571226470206 EUDAMED
04571226474747 EUDAMED
04571226473832 EUDAMED
Basic UDI-DI
B-04571226470206 EUDAMED
B-04571226474747 EUDAMED
B-04571226473832 EUDAMED
EMDN Code
W0105090105 SYPHILIS - RT & POC EUDAMED
W0105094002 STANDARDS AND CALIBRATORS INFECTIOUS IMMUNOLOGY - RT & POC EUDAMED
W0105090303 HIV AG/AB COMBI - RT & POC EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Class IVD Annex II List A EUDAMED
Market of Registration
Netherlands EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMEDEUDAMED

Animal Tissues

Yes

EUDAMEDEUDAMED

Microbial Substances

No

EUDAMED

Reagent

No

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

Yes

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Determine by Abbott Diagnostics Medical Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Abbott Diagnostics Medical Co., Ltd.
EUDAMED SRN
JP-MF-000009543
Authorised Representative
MDSS GmbH DE-AR-000005430

Sources (3)

  • EUDAMED d60f7c89-7168-4311-9089-fa829d4a34b5 61 fields · synced Jul 29, 2026
  • EUDAMED e9e8de25-7cef-473e-8916-93f7da857c28 61 fields · synced May 17, 2026
  • EUDAMED 4402efde-3909-4945-8c96-bef927dcfd02 61 fields · synced May 19, 2026