PCR-CE FMR1 Kit

by Xiamen Biofast Biotechnology Co., Ltd. China EUDAMED

Ref 04110002Model 96 Tests/Kit EMDN W0106010104

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-06975358885019 Basic UDI-DI	Date25 Oct 2022Registered	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Withdrawn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

Device Name: PCR-CE FMR1 Kit
Model / Reference: 96 Tests/Kit, 04110002

Primary DI / UDI-DI: 06975358885019
Basic UDI-DI: B-06975358885019
EMDN Code: W0106010104 Fragile x syndrome

Device Class: Class IVD General
Market of Registration: Austria

Manufacturer details

EUDAMED SRN: CN-MF-000027220
Authorised representative: Lotus NL B.V. NL-AR-000000121

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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 1971549c-4458-4070-9c86-a5a76956b317 61 fields · synced 22 Oct 2026