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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

8323439 — IVDD — General IVDD by Dräger Safety AG & Co.…

MD Atlas
Dräger Safety AG & Co. KGaA

EUDAMED last updated this device on Nov 27, 2025

8323439

B-04048675682738

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Dräger Safety AG & Co. KGaA
UDI-DI code: 04048675682738
Reference / catalog number: 8323439

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Manufacturer information

Organization name: Dräger Safety AG & Co. KGaA
SRN: DE-MF-000014172
Manufacturer status: Active

Critical warnings

5 warnings recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW032
EUDAMED did not publish a description for this code.
CW168
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 04048675682738
Basic UDI-DI: B-04048675682738
Reference / catalog number: 8323439
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: The Oral Fluid Dräger DrugTest is a rapid immunoassay intended for the use with the DrugTest Analyzer for the qualitative detection of oral fluid (cocaine, opiates, cannabis, amphetamine, methamphetamine)
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0102090106COCAINE + COCAINE METABOLITES
W0102090113OPIATES
W0102090105CANNABINOIDS
W0102090102AMPHETAMINE/METHAMPHETAMINE SPECIFIC

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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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.