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Rr-10

EUDAMED

Class A (EU MDR)

Ref BC479026

by Sysmex Corporation

Identity

Trade Name
RR-10 EUDAMED
Device Name
Reservoir Tank RR-10 EUDAMED
Model / Reference
BC479026 EUDAMED

Identifiers

Primary DI / UDI-DI
04987562428335 EUDAMED
Basic UDI-DI
4987562ReservoirTank9C EUDAMED
EMDN Code
W02029080 VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - HARDWARE ACCESSORIES 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

Rr-10 by Sysmex Corporation — 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

Manufacturer
Sysmex Corporation
EUDAMED SRN
JP-MF-000014037
Authorised Representative
Sysmex Europe SE DE-AR-000022333

Sources (1)

  • EUDAMED 315a76ff-f584-475a-9bbc-ce9e3bc1194b 61 fields · synced Jun 19, 2026