EasyNAT HSV 1&2 Assay

by Ustar Biotechnologies (Hangzhou) Ltd. China EUDAMED

Ref U20304 EMDN W0105040311

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number697349224U2030042C000FJ Basic UDI-DI	Date12 Jul 2023Registered	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Withdrawn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 22 Oct 2026

Model / Reference: U20304

Primary DI / UDI-DI: 06973492240152
Basic UDI-DI: 697349224U2030042C000FJ
EMDN Code: W0105040311 Hsv - na reagents

Device Class: Class C
Market of Registration: Netherlands

Manufacturer details

EUDAMED SRN: CN-MF-000014615
Authorised representative: Lotus NL B.V. NL-AR-000000121

Other devices from Ustar Biotechnologies (Hangzhou) Ltd.

Sample Reagent

Class A
MultNAT Carba-R Assay

Class C
PortNAT TB Assay

Class C
MultNAT GBS Assay

Class C
MultNAT MTC/RIF Assay

Class C
Sample Collection and Preservation Medium

Class A

See all devices from Ustar Biotechnologies (Hangzhou) Ltd. →

Properties & raw data

Show properties, registry sources and raw records

Reagent
Professional Testing

Other properties (9)

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

Sources (1)

EUDAMED 19e41cf1-ad5d-4eb1-8c66-9f6b58f91b07 61 fields · synced 22 Oct 2026