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Auto Hematology Analyzer

EUDAMED

Class A (EU MDR)

Ref BS010Ref BS009

by Biobase Biodustry(Shandong) Co., Ltd.

Identity

Trade Name
Auto Hematology Analyzer EUDAMED
5-Part Auto Hematology Analyzer EUDAMED
Device Name
Auto Hematology Analyzer EUDAMED
5-Part Auto Hematology Analyzer EUDAMED
Model / Reference
BS010 EUDAMED
BS009 EUDAMED

Identifiers

Primary DI / UDI-DI
06936895300380 EUDAMED
06936895300397 EUDAMED
06936895300403 EUDAMED
06936895300366 EUDAMED
06936895300342 EUDAMED
06936895300373 EUDAMED
Basic UDI-DI
6936895BS01023 EUDAMED
6936895BS0092J EUDAMED
EMDN Code
W0202010201 AUTOMATED 3 PART HEMATOLOGY ANALYSERS EUDAMED
W0202010101 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr) 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

Auto Hematology Analyzer by Biobase Biodustry(Shandong) Co., Ltd. — 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
Biobase Biodustry(Shandong) Co., Ltd.
EUDAMED SRN
CN-MF-000025015
Authorised Representative
Luxus Lebenswelt GmbH DE-AR-000005110

Sources (10)

  • EUDAMED 1932c826-ccd0-47d4-9d05-d31b7622c9ef 61 fields · synced Oct 6, 2026
  • EUDAMED 7f07284a-4fa6-4ee1-a321-bb005edbf54a 61 fields · synced May 17, 2026
  • EUDAMED d0aa9458-0481-4e10-ad7c-61b7aabcd8fe 61 fields · synced May 19, 2026
  • EUDAMED 56b42642-7ac8-4e04-9579-f08f489c98e1 61 fields · synced May 19, 2026
  • EUDAMED 7185b6e2-950d-4fcc-867b-ac0eb3e99e15 61 fields · synced May 19, 2026
  • EUDAMED aad10225-214a-4e6a-904d-501743785166 61 fields · synced May 19, 2026
  • EUDAMED 86384276-8fb7-45f4-84e5-7c7e697c764f 61 fields · synced Jul 9, 2026
  • EUDAMED 539d6954-2274-4c67-bd9a-25d94c2a0467 61 fields · synced Jul 11, 2026
  • EUDAMED 969a8b51-4883-4a4e-980b-cdc50568f9be 61 fields · synced Jul 13, 2026
  • EUDAMED 18834a6b-9b47-4c8e-996a-ffdf13103260 61 fields · synced Jul 14, 2026