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Organization name
UDI-DI code
Reference / catalog number

ART 402K SAM 2PX Starter kit I - AX — Class I MDR

MD Atlas
SAM Präzisionstechnik GmbH

EUDAMED last updated this device on Jul 22, 2025

ART 402K SAM 2PX Starter kit I - AX

425137579000A3

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SAM Präzisionstechnik GmbH
UDI-DI code: 04251375790171
Reference / catalog number: ART 402K

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Manufacturer information

Organization name: SAM Präzisionstechnik GmbH
SRN: DE-MF-000046397
Manufacturer status: Active

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: ART 402K SAM 2PX Starter kit I - AX
UDI-DI code: 04251375790171
Basic UDI-DI: 425137579000A3
Reference / catalog number: ART 402K
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: 1
Additional product description: SAM 2PX Starter Kit I - AX
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q0199ODONTOLOGY DEVICES - OTHER

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

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.

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