Male factor infertility detection kit

by Xiamen Biofast Biotechnology Co., Ltd. China EUDAMED

Ref 04110008 EMDN W01021399

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-06975358885316 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Withdrawn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 24 Oct 2026

Device Name: Male factor infertility detection kit
Model / Reference: 04110008

Primary DI / UDI-DI: 06975358885316
Basic UDI-DI: B-06975358885316
EMDN Code: W01021399 Cardiac markers - other

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 33829fba-64f8-4499-9478-ac8bd83da70a 61 fields · synced 24 Oct 2026