Nucleic Acid Extraction Reagents(Magnetic Bead)

EUDAMED

Class A (EU MDR)

Ref MTQ064Model T-16,T-32,T-48,T-64,T-96,T-200,T-960

by Singuway Biotech Inc.

Identity

Trade Name: Nucleic Acid Extraction Reagents(Magnetic Bead) EUDAMED
Device Name: Nucleic Acid Extraction Reagents(Magnetic Bead) EUDAMED
Model / Reference: T-16,T-32,T-48,T-64,T-96,T-200,T-960 EUDAMED
MTQ064 EUDAMED

Identifiers

Primary DI / UDI-DI: 06974081870514 EUDAMED
Basic UDI-DI: 697408187MTQVT 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: France 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

Nucleic Acid Extraction Reagents(Magnetic Bead) by Singuway Biotech Inc. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Nucleic acid extraction/isolation kit IVD.

Whole Blood DNA Extraction Kit (Magnetic Bead Method) — JIANGSU BIOPERFECTUS TECHNOLOGIES CO., LTD. · Class A
abGenix™ Viral DNA and RNA Extraction Kit II (Plate) — AITbiotech Pte Ltd · Class A
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	697408187MTQVT	Class A	Active

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Manufacturer

Manufacturer: Singuway Biotech Inc.
EUDAMED SRN: CN-MF-000027180
Authorised Representative: CMC Medical Devices & Drugs SL ES-AR-000000293

Sources (1)

EUDAMED d6660edb-e16a-4341-b131-4189d97dcdc6 61 fields · synced Jun 19, 2026