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Magnetic Bead DNA/RNA Purification Kit

EUDAMED

Class A (EU MDR)

Ref 64T/Box (Pre-filled), 16T/Plate × 4plates Model 20T/Box (DT6) (Pre-filled), 1T/Strip × 20strips 40T/Box (Pre-filled), 10T/Plate × 4plates 20T/Box (Pre-filled), 5T/Plate × 4plates 64T/Box (Pre-filled), 16T/Plate × 4plates

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
20T/Box (DT6) (Pre-filled), 1T/Strip × 20strips 40T/Box (Pre-filled), 10T/Plate × 4plates 20T/Box (Pre-filled), 5T/Plate × 4plates 64T/Box (Pre-filled), 16T/Plate × 4plates EUDAMED
64T/Box (Pre-filled), 16T/Plate × 4plates EUDAMED

Identifiers

Primary DI / UDI-DI
06979458030096 EUDAMED
Basic UDI-DI
697945803EH03PE 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

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

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

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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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 (1)

  • EUDAMED eac33ead-12e0-4d24-adcc-fc7add1acbf1 61 fields · synced Jun 9, 2026