Pathogen Nucleic Acid Extraction Kit

EUDAMED

Class A (EU MDR)

Ref KS148-BYTQ-B24Model Type A: 100 tests/kit Type B: 24 tests/kit Type B: 48 tests/kit Type B: 96 tests/kit Type C: 96 tests/kit Type D: 6×16 tests/kit

by Guangzhou KingCreate Biotechnology Co., Ltd.

Identity

Device Name: Pathogen Nucleic Acid Extraction Kit EUDAMED
Model / Reference: Type A: 100 tests/kit Type B: 24 tests/kit Type B: 48 tests/kit Type B: 96 tests/kit Type C: 96 tests/kit Type D: 6×16 tests/kit EUDAMED
KS148-BYTQ-B24 EUDAMED

Identifiers

Primary DI / UDI-DI: 06974987421438 EUDAMED
Basic UDI-DI: 697498742KS1480014Y EUDAMED
Direct Marketing DI: 06974987421438 EUDAMED
EMDN Code: W0105900101 REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS EUDAMED

Classification

Device Class: Class A EUDAMED
Market of Registration: Germany EUDAMED

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

New Device

EUDAMED

Category: Nucleic acid extraction/isolation kit IVD

Pathogen Nucleic Acid Extraction Kit by Guangzhou KingCreate Biotechnology Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Nucleic acid extraction/isolation kit IVD.

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Nucleic Acid Extraction Kit — Shandong Bohong Gene Technology Co., Ltd. · Class A
HPLC column — Immundiagnostik AG · Class A
VIRCLIA® EXTRACTION SOLUTION — Vircell, S.L · Class A
ViraSens Total Nucleic Acid Purification Kit — Vitrosens Biotechnology Inc. · Class A
Nucleic Acid Extraction Kit — Bioteke Corporation (Wuxi) Co., Ltd. · Class A
MagPure RNA Kit — Chaozhou Hybribio Biochemistry Ltd. · Class A

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDR	697498742KS1480014Y	Class A	Active

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Manufacturer

Manufacturer: Guangzhou KingCreate Biotechnology Co., Ltd.
EUDAMED SRN: CN-MF-000032033
Authorised Representative: Umedwings Netherlands B.V. NL-AR-000000444

Sources (1)

EUDAMED b02bd48a-c6cf-404a-b714-650881ada6db 61 fields · synced Jun 18, 2026