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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

6002-310 — IVDR Class A IVDR by VitalScientific B.V.

MD Atlas
VitalScientific B.V.

EUDAMED last updated this device on Dec 29, 2025

6002-310

37017008Microlab-seriesHC

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: 03701700860037
Reference / catalog number: 6002-310

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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: 03701700860037
Basic UDI-DI: 37017008Microlab-seriesHC
Reference / catalog number: 6002-310
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 analyzer is a semi-automated chemistry analyzer, to be used in combination with certain reagents for in vitro diagnostic measurement of analytes in samples of serum, plasma, urine and aqueous standard solutions. The analyzer is designed as an ´open´ system. Most clinical chemistry tests that require a photometric measurement can be adapted for the system. The analyzer is intended for use in clinical chemistry laboratories where the workload is of low quantity. The analyzer must be operated by qualified and trained personnel.
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)03701700860037

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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.

W02010199CHEMISTRY INSTRUMENTS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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