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Master Diagnóstica

EUDAMED

Class A (EU MDR)

Ref MAD-000230QK-10Model MAD-000230QK

by Vitro, S.a.

Identity

Trade Name
Master Diagnóstica EUDAMED
Device Name
Master Polymer Plus Detection System (Phosphatase) (Incl. AP Chromogen) EUDAMED
Model / Reference
MAD-000230QK EUDAMED
MAD-000230QK-10 EUDAMED

Identifiers

Primary DI / UDI-DI
08435421215108 EUDAMED
Basic UDI-DI
8435421200453XZ EUDAMED
Direct Marketing DI
08435421215108 EUDAMED
EMDN Code
W01030711 IMMUNOHISTOLOGY KITS EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Spain 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

New Device

No

EUDAMED

Category: Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry

Master Diagnóstica by Vitro, S.a. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

Manufacturer
Vitro, S.a.
EUDAMED SRN
ES-MF-000001498

Sources (1)

  • EUDAMED 4a4dc2b7-5c98-4fc0-b354-a2e7e5fb0e10 61 fields · synced Jun 18, 2026