Magnetic Bead DNA/RNA Purification Kit

EUDAMED

Class A (EU MDR)

Ref 32T/Box (Pre-filled), 8T/Plate × 4platesModel 64T/Box (Pre-filled), 16T/Plate × 4plates 32T/Box (Pre-filled), 8T/Plate × 4plates 20T/Box (DT6) (Pre-filled), 1T/Strip × 20strips

by Xi'an Huawei Technology Co., Ltd.

Identity

Trade Name: Magnetic Bead DNA/RNA Purification Kit EUDAMED
Device Name: Magnetic Bead DNA/RNA Purification Kit EUDAMED
Model / Reference: 64T/Box (Pre-filled), 16T/Plate × 4plates 32T/Box (Pre-filled), 8T/Plate × 4plates 20T/Box (DT6) (Pre-filled), 1T/Strip × 20strips EUDAMED
32T/Box (Pre-filled), 8T/Plate × 4plates EUDAMED

Identifiers

Primary DI / UDI-DI: 06979458030119 EUDAMED
Basic UDI-DI: 697945803EH04PG 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: Austria 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

Magnetic Bead DNA/RNA Purification Kit by Xi'an Huawei Technology Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS

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Also classified as Nucleic acid extraction/isolation kit IVD.

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HPLC column — Immundiagnostik AG · Class A
VIRCLIA® EXTRACTION SOLUTION — Vircell, S.L · Class A
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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	697945803EH04PG	Class A	Active

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Manufacturer

Manufacturer: Xi'an Huawei Technology Co., Ltd.
EUDAMED SRN: CN-MF-000051653
Authorised Representative: SUNGO Europe B.V. NL-AR-000000247

Sources (2)

EUDAMED 5d9a8473-9ab5-40e7-a2cd-eabe01ee4eff 61 fields · synced Sep 17, 2026
EUDAMED 5d9a8473-9ab5-40e7-a2cd-eabe01ee4eff-1 61 fields · synced Jun 10, 2026