EUDAMED last updated this device on Jul 22, 2026

β-hCG Test Cassette

B-FI-BHCG-302GG

On the marketIVDD — General

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 →: D-FI-BHCG-302GG
Reference / catalog number: FI-BHCG-302

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.

β-hCG Test Cassette is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Hangzhou Alltest Biotech.Co.,Ltd.. Placed on the EU market in Austria. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: β-hCG Test Cassette
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 →: D-FI-BHCG-302GG
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-FI-BHCG-302GG
Reference / catalog number: FI-BHCG-302
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

Classification

Risk category: IVDD — General
Applicable legislation: —
Status: On the market

Device details

Quantity: 1
Additional product description: A rapid test that quantatively detects the β-hCG level in Serum/Plasma specimen
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

D-FI-BHCG-302GG

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

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EMDN nomenclature code(s)

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

W0102050213FREE BETA HCG (PRENATAL SCREENING)

Critical warnings

No critical warnings reported for this device.

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Austria; available across 32 countries total.

Country	On market since	Until
AustriaPrimary placement	—	Still on market
Belgium	—	Still on market
Bulgaria	—	Still on market
Cyprus	—	Still on market
Czechia	—	Still on market
Germany	—	Still on market
Denmark	—	Still on market
Estonia	—	Still on market
EL	—	Still on market
Spain	—	Still on market
Finland	—	Still on market
France	—	Still on market
Croatia	—	Still on market
Hungary	—	Still on market
Ireland	—	Still on market
Iceland	—	Still on market
Italy	—	Still on market
Liechtenstein	—	Still on market
Lithuania	—	Still on market
Luxembourg	—	Still on market
Latvia	—	Still on market
Malta	—	Still on market
Netherlands	—	Still on market
Norway	—	Still on market
Poland	—	Still on market
Portugal	—	Still on market
Romania	—	Still on market
Sweden	—	Still on market
Slovenia	—	Still on market
Slovakia	—	Still on market
Türkiye	—	Still on market
XI	—	Still on market

Related searches

IVDD — General medical devices in EUDAMED

Device identification

Trade name: β-hCG Test Cassette
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 →: D-FI-BHCG-302GG
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-FI-BHCG-302GG
Reference / catalog number: FI-BHCG-302
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

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

Market distribution

Primary placement in Austria; available across 32 countries total.

Country	On market since	Until
AustriaPrimary placement	—	Still on market
Belgium	—	Still on market
Bulgaria	—	Still on market
Cyprus	—	Still on market
Czechia	—	Still on market
Germany	—	Still on market
Denmark	—	Still on market
Estonia	—	Still on market
EL	—	Still on market
Spain	—	Still on market
Finland	—	Still on market
France	—	Still on market
Croatia	—	Still on market
Hungary	—	Still on market
Ireland	—	Still on market
Iceland	—	Still on market
Italy	—	Still on market
Liechtenstein	—	Still on market
Lithuania	—	Still on market
Luxembourg	—	Still on market
Latvia	—	Still on market
Malta	—	Still on market
Netherlands	—	Still on market
Norway	—	Still on market
Poland	—	Still on market
Portugal	—	Still on market
Romania	—	Still on market
Sweden	—	Still on market
Slovenia	—	Still on market
Slovakia	—	Still on market
Türkiye	—	Still on market
XI	—	Still on market

β-hCG Test Cassette

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

Certificates covering this device

Related devices