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MagPro™ Magnetic Bead-Based Automated NA Extraction System - MGX-16

EUDAMED

Class A (EU MDR)

Ref MGX-16

by Vitrosens Biotechnology Inc.

Identity

Trade Name
MagPro™ Magnetic Bead-Based Automated NA Extraction System - MGX-16 EUDAMED
Device Name
Magnetic Bead-Based Automated NA Extraction System - MGX-16 EUDAMED
Model / Reference
MGX-16 EUDAMED

Identifiers

Primary DI / UDI-DI
08684595032350 EUDAMED
Basic UDI-DI
868459503MGX16QE EUDAMED
EMDN Code
W02050399 NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - OTHER EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

No

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

Yes

EUDAMED

New Device

No

EUDAMED

MagPro™ Magnetic Bead-Based Automated NA Extraction System - MGX-16 by Vitrosens Biotechnology Inc. — Class A — IVDR — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

Manufacturer
Vitrosens Biotechnology Inc.
EUDAMED SRN
TR-MF-000026452

Sources (1)

  • EUDAMED 95d0a779-0bb2-43b9-bb71-d81707231b93 61 fields · synced Jul 11, 2026