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Bacteria Genomic DNA Purification Kit

EUDAMED

Class A (EU MDR)

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

by Xi'an Huawei Technology Co., Ltd.

Identity

Trade Name
Bacteria Genomic DNA Purification Kit EUDAMED
Device Name
Bacteria Genomic DNA Purification Kit EUDAMED
Model / Reference
20T/Box (Pre-filled), 5T/Plate × 4plates 64T/Box (Pre-filled), 16T/Plate × 4plates 20T/Box (DT6) (Pre-filled), 1T/Strip × 20strips EUDAMED
64T/Box (Pre-filled), 16T/Plate × 4plates EUDAMED

Identifiers

Primary DI / UDI-DI
06979458030232 EUDAMED
Basic UDI-DI
697945803EH07PN 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

Bacteria Genomic DNA 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 (2)

  • EUDAMED f76a0cc4-68bd-43bf-bad6-b78c58376acf 61 fields · synced Jun 19, 2026
  • EUDAMED f76a0cc4-68bd-43bf-bad6-b78c58376acf-1 61 fields · synced Jun 10, 2026