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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

6003-404 — IVDR Class A IVDR by VitalScientific B.V.

MD Atlas
VitalScientific B.V.

EUDAMED last updated this device on Jan 29, 2026

6003-404

37017008ProM-SeriesSL

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: 03701700864783
Reference / catalog number: 6003-404

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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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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

No critical warnings reported for this device.

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Market distribution

Primary placement in Netherlands; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 03701700864783
Basic UDI-DI: 37017008ProM-SeriesSL
Reference / catalog number: 6003-404
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: Automated clinical chemistry system intended for use in clinical laboratories. It is intended to be used for a variety of assay methods that have been applied to spectro-photometric and electrochemical techniques. The system has two core modules: one consisting of a spectrophotometric system for measurement of analytes using spectro-photometric techniques, such as end point, rate and turbidimetric assays. The second module is an electrometer used for measurement of electrolytes.
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
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Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)03701700864783

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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.

W0201010105CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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