Data from EUDAMED, last updated Jun 11, 2026

FSH Menopause Rapid Test

B-06974566303926

1 reference

IVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk category: IVDD — General
Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.

Data from EUDAMED, last updated Jun 11, 2026

B-06974566303926

1 reference

IVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk category: IVDD — General
Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.

Device family identification

Device name: FSH Menopause Rapid Test
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: B-06974566303926
Device model: 50Tests/Kit
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: EUDAMED
Version date: May 11, 2026

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk category: IVDD — General
Status: On the market

Name: Zhuhai Encode Medical Engineering Co., Ltd.
SRN An SRN is the unique EUDAMED identifier assigned to a manufacturer, authorised representative or importer when it registers as an actor. View in glossary →: CN-MF-000019361
Country: China
Email: pem01@encode.com.cn

Name: Medunion S.L.
SRN An SRN is the unique EUDAMED identifier assigned to a manufacturer, authorised representative or importer when it registers as an actor. View in glossary →: ES-AR-000019366
Country: Spain
Phone: +34644173535

ReagentProfessional testing

European Medical Device Nomenclature — the EU product classifications carried across this device family's references.

Device family identification

Device name: FSH Menopause Rapid Test
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: B-06974566303926
Device model: 50Tests/Kit
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: EUDAMED
Version date: May 11, 2026

Manufacturer & authorised representative

Name: Zhuhai Encode Medical Engineering Co., Ltd.
SRN An SRN is the unique EUDAMED identifier assigned to a manufacturer, authorised representative or importer when it registers as an actor. View in glossary →: CN-MF-000019361
Country: China
Email: pem01@encode.com.cn

Name: Medunion S.L.
SRN An SRN is the unique EUDAMED identifier assigned to a manufacturer, authorised representative or importer when it registers as an actor. View in glossary →: ES-AR-000019366
Country: Spain
Phone: +34644173535

References

1 reference

Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
FSH Menopause Rapid Test	`FFS-10150`	`06974566303926`	1	On the market