Ultra-fast DNA Library Prep Kit

by Qitan Taike Biotechnology Ltd., Chengdu China EUDAMED

Ref OS004011 EMDN W010699

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number697601989OS004N5 Basic UDI-DI	Date13 Nov 2025Registered	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference: OS004011

Primary DI / UDI-DI: 06976019890120
Basic UDI-DI: 697601989OS004N5
EMDN Code: W010699 Genetic tests - other

Device Class: Class A
Market of Registration: Greece

Manufacturer details

EUDAMED SRN: CN-MF-000040515
Authorised representative: MedPath GmbH DE-AR-000000087

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Properties & raw data

Show properties, registry sources and raw records

Reagent
Professional Testing

Other properties (9)

Sterile: No
Human Tissues: No
Animal Tissues: No
Microbial Substances: No
Self Testing: No
Near-Patient Testing: No
Companion Diagnostics: No
Surgical Instrument: No
New Device: No

Sources (1)

EUDAMED e7352b43-fd14-4f33-a31c-24eada4f3e8e 61 fields · synced 22 Oct 2026