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Nucleic Acid Extraction System

EUDAMED

Class A (EU MDR)

Ref Natch 24Model Natch 24, Natch 48, Natch 96

by Sansure Biotech Inc.

Identity

Trade Name
Nucleic Acid Extraction System EUDAMED
Device Name
Nucleic Acid Extraction System EUDAMED
Model / Reference
Natch 24, Natch 48, Natch 96 EUDAMED
Natch 24 EUDAMED

Identifiers

Primary DI / UDI-DI
06955792712980 EUDAMED
Basic UDI-DI
69557927Natch000000012L EUDAMED
Direct Marketing DI
06955792712980 EUDAMED
EMDN Code
W02069099 VARIOUS SAMPLE PROCESSING INSTRUMENTS - 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

Nucleic Acid Extraction System by Sansure Biotech Inc. — 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-000011392
Authorised Representative
Obelis s.a. BE-AR-000000106

Sources (1)

  • EUDAMED 3ad7f26e-bee3-4ce2-8fd5-667a03736a1c 61 fields · synced Jun 18, 2026