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Nucleic Acid Purification system

EUDAMED

Class A (EU MDR)

Ref INST020024CEModel CaptureRevo NAE24

by Singlera Genomics (jiangsu) Ltd.

Identity

Trade Name
Nucleic Acid Purification System EUDAMED
Device Name
Nucleic Acid Purification system EUDAMED
Model / Reference
CaptureRevo NAE24 EUDAMED
INST020024CE EUDAMED

Identifiers

Primary DI / UDI-DI
06975970650019 EUDAMED
Basic UDI-DI
697597065021QE EUDAMED
EMDN Code
W02050106 DNA GENOMIC PREPARATION DEVICES EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Spain 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 Purification system by Singlera Genomics (jiangsu) 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-000033428
Authorised Representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Sources (2)

  • EUDAMED 893ff847-582e-4e6e-ba1c-dae3d584a57d 61 fields · synced Jun 19, 2026
  • EUDAMED 15aebd1e-90d9-4c3d-8097-bafb279d9b40 61 fields · synced Jun 19, 2026