FSH Control

by Zhejiang Orient Gene Biotech Co., Ltd China EUDAMED

Ref FAFSH-PN20

EMDN W0102152002

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-FAFSH-PN207P Basic UDI-DI	Date18 May 2026Registered	StatusActive

Coverage

1 jurisdiction

Expiring (legacy directive)
Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference: FAFSH-PN20

Primary DI / UDI-DI: D-FAFSH-PN207P
Basic UDI-DI: B-FAFSH-PN207P
EMDN Code: W0102152002 Hormone controls

Device Class: Class IVD General
Market of Registration: Germany

Manufacturer details

EUDAMED SRN: CN-MF-000017965
Authorised representative: CMC Medical Devices & Drugs SL ES-AR-000000293

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See all devices from Zhejiang Orient Gene Biotech Co., Ltd. →

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 4a7dbfa2-d12e-423e-a106-b14fb87d9486 61 fields · synced 24 Oct 2026