EUDAMED last updated this device on Jul 10, 2026

ZuhauseTEST FSH Rapid Test Midstream

B-04260173434118

On the marketIVDD — Self-testing

Applicable legislation: —
Organization name: Hangzhou Alltest Biotech.Co.,Ltd.
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 04260173434118
Reference / catalog number: FFS-103H

Regulatory classification unavailableThis product's Basic UDI record hasn't been published in EUDAMED yet. Classification and compliance details will appear automatically once EUDAMED publishes it.

ZuhauseTEST FSH Rapid Test Midstream is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — Self-testing. Manufactured by Hangzhou Alltest Biotech.Co.,Ltd.. Placed on the EU market in Ireland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: ZuhauseTEST FSH Rapid Test Midstream
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 04260173434118
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-04260173434118
Reference / catalog number: FFS-103H
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 →: GS1

Classification

Risk category: IVDD — Self-testing
Applicable legislation: —
Status: On the market

Device details

Quantity: 1
Additional product description: The FSH Rapid Test Midstream (Urine) is a rapid chromatographic immunoassay for the qualitative detection of follicle stimulating hormone (FSH) in urine to aid in the detection of menopause.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)04260173434118

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

W0102160301FSH - RT & POC

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

Consult instructions for use

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Ireland; available across 2 countries total.

Country	On market since	Until
IrelandPrimary placement	—	Still on market
Germany	—	Still on market

Related searches

IVDD — Self-testing medical devices in EUDAMED

Device identification

Trade name: ZuhauseTEST FSH Rapid Test Midstream
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 04260173434118
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-04260173434118
Reference / catalog number: FFS-103H
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 →: GS1

Device details

Quantity: 1
Additional product description: The FSH Rapid Test Midstream (Urine) is a rapid chromatographic immunoassay for the qualitative detection of follicle stimulating hormone (FSH) in urine to aid in the detection of menopause.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Certificates

Certificate health across this manufacturer's portfolio.

V76 095123 0019Supplemented
Technical documentation
Notified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
: TÜV SÜD Product Service GmbH (0123)Expiry: Jul 8, 2030
V76 095123 0020Supplemented
Technical documentation
Notified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
: TÜV SÜD Product Service GmbH (0123)Expiry: Aug 11, 2030
EU-TDA-FI-51326-800081-2026Issued
Technical documentation
Notified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
: Sertio Oy (3018)Expiry: Apr 16, 2031
EU-QMS-FI-08820-800081-2026Issued
Quality management system
Notified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
: Sertio Oy (3018)Expiry: Apr 16, 2031
EU-QMS-FI-08820-800081-2026Issued
Quality management system
Notified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
: Sertio Oy (3018)Expiry: Apr 16, 2031
CN26/00001622Issued
Quality management system: SGS Belgium NV (1639)Expiry: Mar 10, 2031

Country

On market since

Until

IrelandPrimary placement

—

Still on market

Germany

—

Still on market

ZuhauseTEST FSH Rapid Test Midstream

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Market distribution

Related searches

Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates

Related devices

Certificates covering this device