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Automated Pipetting System

EUDAMED

Class A (EU MDR)

Ref SAI-08A

by Jiangsu Bioperfectus Technologies Co., Ltd.

Identity

Trade Name
Automated Pipetting System EUDAMED
Device Name
Automated Pipetting System EUDAMED
Model / Reference
SAI-08A EUDAMED

Identifiers

Primary DI / UDI-DI
06973342006990 EUDAMED
Basic UDI-DI
697334200SAI08ABG EUDAMED
EMDN Code
W0503020199 PIPETTES - 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

Automated Pipetting System by Jiangsu Bioperfectus Technologies 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-000014691
Authorised Representative
MedNet EC-REP GmbH DE-AR-000000002

Sources (1)

  • EUDAMED c70d0202-903c-411b-8cb9-750c7406adbb 61 fields · synced Jul 27, 2026