T4 Test Kit (FIA)

by Guangdong Wesail Biotech Co., Ltd. China EUDAMED

Ref BA0210Model 20 tests/kit EMDN W01020407

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-06973841000956 Basic UDI-DI	Date11 Nov 2024Registered	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference: 20 tests/kit, BA0210

Primary DI / UDI-DI: 06973841000956
Basic UDI-DI: B-06973841000956
EMDN Code: W01020407 Thyroxine

Device Class: Class IVD General
Market of Registration: Romania

Manufacturer details

EUDAMED SRN: CN-MF-000008828
Authorised representative: Lotus NL B.V. NL-AR-000000121

Other devices from Guangdong Wesail Biotech Co., Ltd.

Luteinizing Hormone Test Kit (Immunofluorescence)

IVD General
N-terminal pro-Brain Natriuretic Peptide Test Kit (Immunofluorescence)

IVD General
High Sensitivity Cardiac Troponin I Test Kit (Immunofluorescence)

IVD General
COVID-19 Ag Test Kit

IVD for self-testing
cTnI/CK-MB/Myo Test Kit (Immunofluorescence)

IVD General
Follicle Stimulating Hormone Test Kit (Immunofluorescence)

IVD General

See all devices from Guangdong Wesail Biotech Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records

Reagent
Near-Patient Testing
Professional Testing

Other properties (7)

Sterile: No
Human Tissues: No
Animal Tissues: No
Microbial Substances: No
Self Testing: No
Companion Diagnostics: No
Surgical Instrument: No

Sources (1)

EUDAMED 98de2132-9b21-4fda-8ec2-1e5cd986378c 61 fields · synced 22 Oct 2026