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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

6004-301 — IVDR Class A IVDR by VitalScientific B.V.

MD Atlas
VitalScientific B.V.

EUDAMED last updated this device on Jan 14, 2026

6004-301

37017008Mach-seriesPP

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: VitalScientific B.V.
UDI-DI code: 03701700860549
Reference / catalog number: 6004-301

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View device family (Basic UDI)

Manufacturer information

Organization name: VitalScientific B.V.
SRN: NL-MF-000021018
Manufacturer status: Active

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Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Netherlands; available across 1 country total.

Country	On market since	Until
NetherlandsPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 03701700860549
Basic UDI-DI: 37017008Mach-seriesPP
Reference / catalog number: 6004-301
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The Selectra Mach5 is an automated clinical chemistry system intended for in vitro diagnostic measurements of analytes in samples derived from the human body. The system is intended for use in clinical laboratories and must be operated by qualified personnel. The system has a core module that consists of a spectrophotometric system.
Additional information URL: No additional information URL provided by the manufacturer.
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)03701700860549

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

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

W0201010101CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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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.