Beiwo

by Hangzhou Beiwo Medical Technology Co., Ltd. 6 variants

Ref BW-MGD2411-A00Model BW-MGD2411-A00 BW-MGD2411-A32 BW-MGD2411-A32-32 BW-MGD2411-A96

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number697557396bwyx007MM Basic UDI-DI 06975573960003UDI-DI	Date10 Aug 2023Registered	StatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name: Pathogen DNA/RNA Purification Kit (Beads)
Model / Reference: BW-MGD2411-A00 BW-MGD2411-A32 BW-MGD2411-A32-32 BW-MGD2411-A96, BW-MGD2411-A00

Primary DI / UDI-DI: 06975573960003
Basic UDI-DI: 697557396bwyx007MM
Direct Marketing DI: 06975573960003
EMDN Code: W01019099 Clinical chemistry reagents - other

Device Class: Class A
EU market of registration: Austria

Manufacturer details

EUDAMED SRN: CN-MF-000027312
Authorised representative: SUNGO Europe B.V. NL-AR-000000247

Other devices from Hangzhou Beiwo Medical Technology Co., Ltd.

Pathogen DNA/RNA Purification Kit (Beads)

Class A
Beiwo

Class A
no

Class A
Beiwo

Class A
Beiwo

Class A
Beiwo

Class A

See all devices from Hangzhou Beiwo Medical Technology Co., Ltd. →

Properties

Reagent
Professional Testing
Companion Diagnostics

Other properties (8)

Sterile: No
Human Tissues: No
Animal Tissues: No
Microbial Substances: No
Self Testing: No
Near-Patient Testing: No
Surgical Instrument: No
New Device: No