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BH-6580 5-Part-Diff Auto Hematology Analyzer

EUDAMED

Class B (EU MDR)

Ref /Model BH-6180、BH-6580、BH-6680、BH-6600、BH-6500、BH-6100

by URIT Medical Electronic Co., Ltd.

Identity

Trade Name
BH-6580 5-Part-Diff Auto Hematology Analyzer EUDAMED
Device Name
5-Part-Diff Auto Hematology Analyzer EUDAMED
Model / Reference
BH-6180、BH-6580、BH-6680、BH-6600、BH-6500、BH-6100 EUDAMED
/ EUDAMED

Identifiers

Primary DI / UDI-DI
06935740730440 EUDAMED
06935740730457 EUDAMED
06935740735285 EUDAMED
Basic UDI-DI
69357407IBH000004ND EUDAMED
Direct Marketing DI
06935740730440 EUDAMED
06935740730457 EUDAMED
06935740735285 EUDAMED
EMDN Code
W0202010103 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - HIGH ROUTINE (Throughput > 120 samples/hr) EUDAMED
W0202010102 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 120 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-6580 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 (3)

  • EUDAMED e464b443-d3a1-4491-8d8c-8cd97b35fccb 61 fields · synced Oct 6, 2026
  • EUDAMED 2e82a542-5fc1-4c4b-9a35-e2dd31c42ec2 61 fields · synced May 19, 2026
  • EUDAMED b3730ad8-26bd-4af9-a3c5-b632a0632540 61 fields · synced May 19, 2026