Nucleic Acid and Microbe Extraction System

by Zybio Inc. China EUDAMED

Ref 0307402Model EXM 3000 Duo

EMDN W02050199

Regulatory status

as of 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number697326286002672K Basic UDI-DI	Date3 Aug 2026Registered	StatusActive

Coverage

1 jurisdiction

Active
Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name: Nucleic Acid and Microbe Extraction System
Model / Reference: EXM 3000 Duo, 0307402

Primary DI / UDI-DI: 06941967242239
Basic UDI-DI: 697326286002672K
EMDN Code: W02050199 Nucleic acid testing instruments except micro-arrays - other

Device Class: Class A
Market of Registration: Netherlands

Manufacturer details

EUDAMED SRN: CN-MF-000003349
Authorised representative: Lotus NL B.V. NL-AR-000000121

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Properties & raw data

Show properties, registry sources and raw records

Surgical Instrument

Other properties (10)

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

Sources (1)

EUDAMED 06941967242239|697326286002672K 61 fields · synced 24 Oct 2026