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Nucleic Acid Extractor System

EUDAMED

Class A (EU MDR)

Ref MultiEx 096Model MultiEx 096

by Guangzhou Four E’s Healthcare Co., Ltd.

Identity

Trade Name
Nucleic Acid Extractor System EUDAMED
Device Name
Nucleic Acid Extractor System EUDAMED
Model / Reference
MultiEx 096 EUDAMED

Identifiers

Primary DI / UDI-DI
06973698770378 EUDAMED
Basic UDI-DI
697369877MultiEx096SQ EUDAMED
EMDN Code
W02050106 DNA GENOMIC PREPARATION DEVICES EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Austria 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

Nucleic Acid Extractor System by Guangzhou Four E’s Healthcare 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-000023274
Authorised Representative
Kingsmead Service B.V. NL-AR-000002066

Sources (1)

  • EUDAMED 6e0d9816-99b9-4d4a-bf24-7b11aa318758 61 fields · synced Jun 18, 2026