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Automatic Nucleic Acid Extractor

EUDAMED

Class A (EU MDR)

Ref MC104801Model MagiCube 48

by Beijing Applied Biological Technologies Co., Ltd.

Identity

Trade Name
Automatic Nucleic Acid Extractor EUDAMED
Device Name
Automatic Nucleic Acid Extractor EUDAMED
Model / Reference
MagiCube 48 EUDAMED
MC104801 EUDAMED

Identifiers

Primary DI / UDI-DI
06974323018018 EUDAMED
Basic UDI-DI
697432301YQ001FD EUDAMED
Direct Marketing DI
06974323018018 EUDAMED
EMDN Code
W02050199 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - 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

Automatic Nucleic Acid Extractor by Beijing Applied Biological Technologies Co., Ltd. — 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

EUDAMED SRN
CN-MF-000012338
Authorised Representative
Luxus Lebenswelt GmbH DE-AR-000005110

Sources (1)

  • EUDAMED 7c7846b1-80e1-4f46-9c09-8178886c6c3d 61 fields · synced Jun 18, 2026