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Cervical Liquid-based Analysis Software

EUDAMED

Class IVD General (EU MDR)

Ref /Model Canaly-100, Canaly-200, Canaly-300

by Shenzhen Reetoo Biotechnology Co., Ltd

Identity

Device Name
Cervical Liquid-based Analysis Software EUDAMED
Model / Reference
Canaly-100, Canaly-200, Canaly-300 EUDAMED
/ EUDAMED

Identifiers

Primary DI / UDI-DI
D-1036F EUDAMED
Basic UDI-DI
B-1036F EUDAMED
EMDN Code
W02020502 CERVICAL SCREENING SYSTEMS EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Special Device Type
-1202 EUDAMED
Market of Registration
Italy 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

No

EUDAMED

Cervical Liquid-based Analysis Software 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 e1b95847-6da6-48ee-8e6c-28db566b72ce 61 fields · synced Jun 19, 2026