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MagCore® Viral Nucleic Acid Extraction Kit

EUDAMED

Class A (EU MDR)

Ref MVN400-01Ref MVN400-06Ref MVN400-02Ref MVN400-05

by RBCBioscience Corp.

Identity

Trade Name
MagCore® Viral Nucleic Acid Extraction Kit EUDAMED
MagCore® Viral nucleic acid extraction kit (high sensitivity) EUDAMED
Device Name
MagCore® System EUDAMED
Model / Reference
MVN400-01 EUDAMED
MVN400-06 EUDAMED
MVN400-02 EUDAMED
MVN400-05 EUDAMED

Identifiers

Primary DI / UDI-DI
34719890671081 EUDAMED
14719890671100 EUDAMED
14719890671087 EUDAMED
34719890671104 EUDAMED
Basic UDI-DI
471989067M0000A9 EUDAMED
EMDN Code
W0105900101 REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Belgium 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

Yes

EUDAMED

New Device

No

EUDAMED

MagCore® Viral Nucleic Acid Extraction Kit by RBCBioscience Corp. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

Manufacturer
RBCBioscience Corp.
EUDAMED SRN
TW-MF-000026757
Authorised Representative
Obelis s.a. BE-AR-000000106

Sources (4)

  • EUDAMED d3aafc15-ff4c-48a8-95f9-de151a414f9d 61 fields · synced Aug 2, 2026
  • EUDAMED 9cc02352-25bf-4468-a5ca-26edb55fffcb 61 fields · synced May 16, 2026
  • EUDAMED 6e8d6725-c8fd-479a-a9fb-52693f875601 61 fields · synced May 17, 2026
  • EUDAMED c1dcc18d-867d-4b72-8fb3-ec7b6dbf09d8 61 fields · synced May 18, 2026