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BH-5380CRP 5-Part-Diff Auto Hematology Analyzer

EUDAMED

Class B (EU MDR)

Ref /Model BH-5380CRP、BH-5160CRP、BH-5160CS

by URIT Medical Electronic Co., Ltd.

Identity

Trade Name
BH-5380CRP 5-Part-Diff Auto Hematology Analyzer EUDAMED
Device Name
5-Part-Diff Auto Hematology Analyzer EUDAMED
Model / Reference
BH-5380CRP、BH-5160CRP、BH-5160CS EUDAMED
/ EUDAMED

Identifiers

Primary DI / UDI-DI
06935740730464 EUDAMED
Basic UDI-DI
69357407IBH000003NB EUDAMED
Direct Marketing DI
06935740730464 EUDAMED
EMDN Code
W0202010101 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr) EUDAMED

Classification

Device Class
Class B 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

BH-5380CRP 5-Part-Diff Auto Hematology Analyzer by URIT Medical Electronic Co., Ltd. — Class B — 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
URIT Medical Electronic Co., Ltd.
EUDAMED SRN
CN-MF-000011840
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (1)

  • EUDAMED 864a018c-8651-47e0-bb9c-f7f7dcda4d5c 61 fields · synced Oct 6, 2026