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Automatic Sample Processing System

EUDAMED

Class A (EU MDR)

Ref H693301Model AutoRuby Dx

by Aperbio Technologies (Suzhou) Co., Ltd

Identity

Device Name
Automatic Sample Processing System EUDAMED
Model / Reference
AutoRuby Dx EUDAMED
H693301 EUDAMED

Identifiers

Primary DI / UDI-DI
06974149860037 EUDAMED
Basic UDI-DI
697414986AutoRubyDxQT EUDAMED
Direct Marketing DI
06974149860037 EUDAMED
EMDN Code
W02069001 AUTOSAMPLERS 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

No

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

Yes

EUDAMED

New Device

No

EUDAMED

Automatic Sample Processing System by Aperbio Technologies (Suzhou) 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-000045149
Authorised Representative
Medunion S.L. ES-AR-000019366

Sources (1)

  • EUDAMED d53d5ab0-5043-4a51-b2fb-c9957d93b9ba 61 fields · synced Jun 18, 2026