← Back to catalogue

Automatic Nucleic Acid Extraction System

EUDAMED

Class A (EU MDR)

Ref 230501Model YN-AP9610

by Yaneng BIOscience (Shenzhen) Co., Ltd.

Identity

Trade Name
Automatic Nucleic Acid Extraction System EUDAMED
Device Name
Automatic Nucleic Acid Extraction System EUDAMED
Model / Reference
YN-AP9610 EUDAMED
230501 EUDAMED

Identifiers

Primary DI / UDI-DI
06955931303116 EUDAMED
Basic UDI-DI
695593130023050001JJ EUDAMED
Direct Marketing DI
06955931303116 EUDAMED
EMDN Code
W02069099 VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Italy 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 Extraction System by Yaneng BIOscience (Shenzhen) 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

EUDAMED SRN
CN-MF-000013666
Authorised Representative
Obelis s.a. BE-AR-000000106

Sources (1)

  • EUDAMED acbc066b-02f7-4c39-8ca0-83054e0e3b0a 61 fields · synced Jun 19, 2026