EUDAMED last updated this device on Jul 17, 2026

AMNIOQUICK Card BSX

B-03532670103738

On the marketIVDD — General

Applicable legislation: —
Organization name: BIOSYNEX
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 →: 03532670103738
Reference / catalog number: 1090005_BSX_C

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.

AMNIOQUICK Card BSX is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by BIOSYNEX. Placed on the EU market in France. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: AMNIOQUICK Card BSX
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 →: 03532670103738
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-03532670103738
Reference / catalog number: 1090005_BSX_C
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 — General
Applicable legislation: —
Status: On the market

Device details

Quantity: 1
Additional product description: Rapid test for detection of IGFBP-1 (Insulin-like growth factor-binding protein 1) with automated readout. Warning: This AMNIOQUICK CARD BSX test as well as all other tests in the BSX range are dedicated to be read and interpreted by the BSX READER supplied separately (ref. 5060029).
Additional information URL: https://www.biosynex.com/
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)03532670103738

EMDN nomenclature code(s)

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

W0102060405INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 1

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 France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	—	Still on market

AMNIOQUICK Card BSX

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

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Manufacturer information

Certificates

Certificates covering this device

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