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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

1140016_SW — IVDD — General IVDD by BIOSYNEX Swiss SA

MD Atlas
BIOSYNEX Swiss SA

EUDAMED last updated this device on May 6, 2026

1140016_SW

B-03532670100454

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: BIOSYNEX Swiss SA
UDI-DI code: 03532670100454
Reference / catalog number: 1140016_SW

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Manufacturer information

Organization name: BIOSYNEX Swiss SA
SRN: CH-MF-000024717
Manufacturer status: Active

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 03532670100454
Basic UDI-DI: B-03532670100454
Reference / catalog number: 1140016_SW
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Rapid multi‑drug test for the qualitative detection of amphetamines (AMP), buprenorphine (BUP), barbiturates (BAR), benzodiazepines (BZO), cocaine (COC), methadone (MTD), methamphetamine (MET), ecstasy (MDMA), morphine (MOP), cannabis (THC), and tricyclic antidepressants (TCA) in urine.
Additional information URL: https://www.biosynex.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0102160511MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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