Detection Kit for Noninvasive Fetal Trisomy（T21, T18, T13）Test (Combinatorial Probe-Anchor Synthesis Sequencing Method)

by Bgi Europe a/S

Ref MFG030008, MFG030007, MFG030009

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-05745000468126 Basic UDI-DI	Date31 Mar 2026Registered	StatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name: Detection Kit for Noninvasive Fetal Trisomy（T21, T18, T13）Test (Combinatorial Probe-Anchor Synthesis Sequencing Method)
Model / Reference: MFG030008, MFG030007, MFG030009

Primary DI / UDI-DI: 05745000468126, 05745000468096, 05745000468133
Basic UDI-DI: B-05745000468126, B-05745000468096, B-05745000468133
EMDN Code: W0106010301, W0106010302, W0106010304

Device Class: Class IVD Annex II List B
EU market of registration: Denmark

Manufacturer details

EUDAMED SRN: DK-MF-000014089

Other devices from Bgi Europe a/S

See all devices from Bgi Europe a/S →

Properties

Human Tissues
Reagent
Professional Testing

Other properties (7)

Sterile: No
Animal Tissues: No
Microbial Substances: No
Self Testing: No
Near-Patient Testing: No
Companion Diagnostics: No
Surgical Instrument: No

Detection Kit for Noninvasive Fetal Trisomy（T21, T18, T13）Test (Combinatorial Probe-Anchor Synthesis Sequencing Method)

Regulatory status

Certificates

Coverage

Specification

Manufacturer details

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Properties

Other properties (7)