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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

03 — Class I MDR by Ksyos Health Management…

MD Atlas
Ksyos Health Management Research B.V.

EUDAMED last updated this device on Nov 13, 2025

03

10069801LHLHDL001SD

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Ksyos Health Management Research B.V.
UDI-DI code: 08720892788122
Reference / catalog number: 03

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View device family (Basic UDI)

Manufacturer information

Organization name: Ksyos Health Management Research B.V.
SRN: NL-MF-000050008
Manufacturer status: Active

Related devices

0110069801TWL001BHOn the market 0210069801BMI001XZOn the market 0410069801OBESQ001FEOn the market

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: 08720892788122
Basic UDI-DI: 10069801LHLHDL001SD
Reference / catalog number: 03
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: Beoogd gebruik: De verhouding tussen LDL-cholesterol en HDL-cholesterol van een patiënt inzichtelijk weer te geven ter ondersteuning van de follow-up zorg bij obesitas. Waarschuwing: Alleen te gebruiken door gekwalificeerd medisch personeel
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

EMDN nomenclature code(s)

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

Z12030201CENTRAL INFORMATION COMPUTING SYSTEMS

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

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