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Hematology Control

EUDAMED

Class IVD General (EU MDR)

Ref /Model RQ-6D,RQ-NRBC,RQ-RET,RQ-BF

by Shenzhen Reetoo Biotechnology Co., Ltd

Identity

Device Name
Hematology Control EUDAMED
Model / Reference
RQ-6D,RQ-NRBC,RQ-RET,RQ-BF EUDAMED
/ EUDAMED

Identifiers

Primary DI / UDI-DI
D-QS2102-01PJ EUDAMED
Basic UDI-DI
B-QS2102-01PJ EUDAMED
EMDN Code
W0103010503 MULTILEVEL BLOOD CONTROLS EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Italy EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

Yes

EUDAMED

Animal Tissues

Yes

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

Hematology Control by Shenzhen Reetoo Biotechnology Co., Ltd — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

EUDAMED SRN
CN-MF-000011699
Authorised Representative
Umedwings Netherlands B.V. NL-AR-000000444

Sources (1)

  • EUDAMED 84826fa4-6773-4b64-a72a-026a1b69f42f 61 fields · synced Jul 26, 2026