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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

Mouthpiece Alcotest 3820/4000… — Class I MDR

MD Atlas
Dräger Safety AG & Co. KGaA

EUDAMED last updated this device on Oct 20, 2025

Mouthpiece Alcotest 3820/4000 Companion 4me

04026056MSBSCmedWS

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Dräger Safety AG & Co. KGaA
UDI-DI code: 04026056016204
Reference / catalog number: 8325250

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Manufacturer information

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

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Oct 10, 2022	Still on market

Device identification

Trade name: Mouthpiece Alcotest 3820/4000 Companion 4me
UDI-DI code: 04026056016204
Basic UDI-DI: 04026056MSBSCmedWS
Reference / catalog number: 8325250
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 5
Additional product description: The mouthpiece is to be used with Dräger Companion 4me (BUDI DI: 04048675A4000medUV)
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V0380DEVICES WITH MEASURING FUNCTIONS - ACCESSORIES

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification