PCR-CE β-Thalassemia Kit

by Xiamen Biofast Biotechnology Co., Ltd. China EUDAMED

Ref 04110020 EMDN W0106010111

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-06975358886009 Basic UDI-DI	Date9 Apr 2026Registered	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Withdrawn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 24 Oct 2026

Model / Reference: 04110020

Primary DI / UDI-DI: 06975358886009
Basic UDI-DI: B-06975358886009
EMDN Code: W0106010111 Thalassaemia

Device Class: Class IVD General
Market of Registration: Netherlands

Manufacturer details

EUDAMED SRN: CN-MF-000027220
Authorised representative: Medunion S.L. ES-AR-000019366

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Properties & raw data

Show properties, registry sources and raw records

Reagent
Professional Testing

Other properties (8)

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

Sources (1)

EUDAMED 2c8e9fed-f1e8-4738-80e6-9aa35468d655 61 fields · synced 24 Oct 2026