Digital Sample Preparation System DNBelab-D4

by Qingdao MGI Tech Co., Ltd. China EUDAMED

Ref 900-000484-00Model DNBelab-D4 EMDN W0299

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number697485688elabB4 Basic UDI-DI	Date3 Jun 2026Registered	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name: Digital Sample Preparation System
Model / Reference: DNBelab-D4, 900-000484-00

Primary DI / UDI-DI: 06974856880007
Basic UDI-DI: 697485688elabB4
Direct Marketing DI: 06974856880007
EMDN Code: W0299 IVD instruments - other

Device Class: Class A
Market of Registration: Latvia

Manufacturer details

EUDAMED SRN: CN-MF-000022546
Authorised representative: Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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Properties & raw data

Show properties, registry sources and raw records

Professional Testing
Surgical Instrument

Other properties (9)

Sterile: No
Human Tissues: No
Animal Tissues: No
Microbial Substances: No
Reagent: No
Self Testing: No
Near-Patient Testing: No
Companion Diagnostics: No
New Device: No

Sources (1)

EUDAMED 7236b7bf-09a0-4600-976b-11b96b8e84fb 61 fields · synced 24 Oct 2026