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Intelligent Fully Automatic Endotoxin And MAT Detection Robot System (Phoenix Q…

EUDAMED

Class A (EU MDR)

Ref Phoenix Q5

by Xiamen Bioendo Technology Co., Ltd.

Identity

Trade Name
Intelligent Fully Automatic Endotoxin And MAT Detection Robot System (Phoenix Q Series) EUDAMED
Device Name
Intelligent fully automatic endotoxin and MAT detection robot system (Phoenix Q series) EUDAMED
Model / Reference
Phoenix Q5 EUDAMED

Identifiers

Primary DI / UDI-DI
06978918720157 EUDAMED
Basic UDI-DI
697891872PQS0012R EUDAMED
EMDN Code
W0201030101 MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput <= 800 test/h) 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

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

Yes

EUDAMED

New Device

No

EUDAMED

Intelligent Fully Automatic Endotoxin And MAT Detection Robot System (Phoenix Q… by Xiamen Bioendo Technology Co., Ltd. — Class A — IVDR — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

EUDAMED SRN
CN-MF-000027676
Authorised Representative
JOYSUN GROUP S.L.U ES-AR-000043666

Sources (1)

  • EUDAMED cf93594e-2b0d-46fd-9f14-a079d414770e 61 fields · synced Jul 28, 2026