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C Reactive Protein (CRP) (Latex)

EUDAMED

Class IVD General (EU MDR)

Ref 514 003Ref 514 000Ref 514 004

by Egyptian Company For Biotechnology-Spectrum Diagnostics

Identity

Trade Name
C Reactive Protein (CRP) (Latex) EUDAMED
Device Name
C Reactive Protein (CRP) (Latex) EUDAMED
Model / Reference
514 003 EUDAMED
514 000 EUDAMED
514 004 EUDAMED

Identifiers

Primary DI / UDI-DI
62230041012674 EUDAMED
62230041012360 EUDAMED
62230041012742 EUDAMED
Basic UDI-DI
B-62230041012674 EUDAMED
B-62230041012360 EUDAMED
B-62230041012742 EUDAMED
EMDN Code
W01021109 C-REACTIVE PROTEIN EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Romania EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

Yes

EUDAMEDEUDAMED

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

C Reactive Protein (CRP) (Latex) by Egyptian Company For Biotechnology-Spectrum Diagnostics — Class IVD General — IVDD — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Egyptian Company For Biotechnology-Spectrum Diagnostics
EUDAMED SRN
EG-MF-000032599
Authorised Representative
MDSS GmbH DE-AR-000005430

Sources (3)

  • EUDAMED d53066f1-e2cd-4f40-ab76-605f42652d2c 61 fields · synced Oct 6, 2026
  • EUDAMED e5ad78d7-b224-46de-adcc-0eb296986f94 61 fields · synced May 17, 2026
  • EUDAMED a94b56aa-5c35-4297-84ee-7ccf2f1d577a 61 fields · synced May 18, 2026