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Automated Hematology Analyzer Lyse

EUDAMED

Class A (EU MDR)

Ref XQ9004YModel LYA-1, LYA-2, LYA-3Ref XQ9008YModel LYC-1, LYC-2Ref XQ9009YRef XQ9007YModel LYE-1

by MedicalSystem Biotechnology Co., Ltd.

Identity

Trade Name
Automated Hematology Analyzer Lyse EUDAMED
Device Name
Automated Hematology Analyzer Lyse EUDAMED
Model / Reference
LYA-1, LYA-2, LYA-3 EUDAMED
XQ9004Y EUDAMED
LYC-1, LYC-2 EUDAMED
XQ9008Y EUDAMED
XQ9009Y EUDAMED
LYE-1 EUDAMED
XQ9007Y EUDAMED

Identifiers

Primary DI / UDI-DI
06970291980821 EUDAMED
06970291980883 EUDAMED
06970291980906 EUDAMED
06970291980869 EUDAMED
Basic UDI-DI
693659579002PB EUDAMED
693659579008PP EUDAMED
693659579007PM EUDAMED
EMDN Code
W0103010103 COMPLETE CELL COUNT EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
France EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

Automated Hematology Analyzer Lyse by Medicalsystem Biotechnology 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
MedicalSystem Biotechnology Co., Ltd.
EUDAMED SRN
CN-MF-000010246
Authorised Representative
Lotus NL B.V. NL-AR-000000121

Sources (4)

  • EUDAMED 32c5866b-f9e7-4059-99d7-9d920f5d9f68 61 fields · synced Jul 21, 2026
  • EUDAMED 1326907d-b07c-47b1-ad42-c3b87b787480 61 fields · synced May 17, 2026
  • EUDAMED fa854ba7-00ec-4cb4-88a2-293bde5b328f 61 fields · synced May 17, 2026
  • EUDAMED b4e69d45-7d45-4aeb-a5ab-039e2590abd3 61 fields · synced May 17, 2026