Pre-NAT II (SY61-EI)

by Suzhou Sym-Bio Lifescience Co., Ltd. China EUDAMED

Ref SY61-EI EMDN W02050106

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number69510458INST_PreNATII6Z Basic UDI-DI	Date25 Nov 2022Registered	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Withdrawn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 25 Oct 2026

Device Name: Automated Workstation
Model / Reference: SY61-EI

Primary DI / UDI-DI: 06951045800039
Basic UDI-DI: 69510458INST_PreNATII6Z
EMDN Code: W02050106 DNA genomic preparation devices

Device Class: Class A
Market of Registration: Netherlands

Manufacturer details

EUDAMED SRN: CN-MF-000012847
Authorised representative: Emergo Europe B.V. NL-AR-000000116

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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 8317780a-1dae-42fa-a7ec-9dbed59c8789 61 fields · synced 25 Oct 2026