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RoboBlot

EUDAMED

Class A (EU MDR)

Ref RB01

by Bee Robotics

Identity

Trade Name
RoboBlot EUDAMED
Device Name
RoboBlot EUDAMED
Model / Reference
RB01 EUDAMED

Identifiers

Primary DI / UDI-DI
05060969430008 EUDAMED
Basic UDI-DI
506096943RB01AQ EUDAMED
EMDN Code
W0201020180 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - 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

RoboBlot by Bee Robotics — 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
Bee Robotics
EUDAMED SRN
GB-MF-000023998
Authorised Representative
CS Life Sciences Europe Ltd IE-AR-000004113

Sources (1)

  • EUDAMED f32f2338-a0be-46f9-977c-ce6c7ca1a75c 61 fields · synced Jun 19, 2026