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Total Protein (Single Reagent)

EUDAMED

Class IVD General (EU MDR)

Ref 310 005Ref 310 001Ref 310 003

by Egyptian Company For Biotechnology-Spectrum Diagnostics

Identity

Trade Name
Total Protein (Single Reagent) EUDAMED
Device Name
Total Protein (Single Reagent) EUDAMED
Model / Reference
310 005 EUDAMED
310 001 EUDAMED
310 003 EUDAMED

Identifiers

Primary DI / UDI-DI
62230041036298 EUDAMED
62230041035826 EUDAMED
62230041036052 EUDAMED
Basic UDI-DI
B-62230041036298 EUDAMED
B-62230041035826 EUDAMED
B-62230041036052 EUDAMED
EMDN Code
W01010230 TOTAL PROTEIN EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

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

Total Protein (Single Reagent) 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

EUDAMED SRN
EG-MF-000032599
Authorised Representative
MDSS GmbH DE-AR-000005430

Sources (3)

  • EUDAMED c56fc8b6-9b9a-4f76-98d1-6112ab69a8ae 61 fields · synced Oct 6, 2026
  • EUDAMED 7b301257-02d9-4400-aa24-79ae3bc3cff7 61 fields · synced May 17, 2026
  • EUDAMED a8a9d349-d60d-4af6-a834-873e8ccc5eec 61 fields · synced May 19, 2026