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Organization name
UDI-DI code
Reference / catalog number

ISE CALIBRATORS — IVDR Class B IVDR by VitalScientific

MD Atlas
VitalScientific

EUDAMED last updated this device on Mar 26, 2026

ISE CALIBRATORS

37017008ISCA049C

On the marketIVDR Class B

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: VitalScientific
UDI-DI code: 03701700824022
Reference / catalog number: ISCA-4222

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Manufacturer information

Organization name: VitalScientific
SRN: FR-MF-000004722
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

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	Jun 6, 2024	Still on market

Device identification

Trade name: ISE CALIBRATORS
UDI-DI code: 03701700824022
Basic UDI-DI: 37017008ISCA049C
Reference / catalog number: ISCA-4222
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: "This in vitro diagnostic device is intended for the calibration of the ISE measurement system of Selectra Pro analyzers equipped with an ISE module (quantitative determination of sodium (Na+), potassium (K+), chloride (Cl-) and total CO2). This in vitro diagnostic device is for professional use only."
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0101050301CALIBRATORS MULTICOMPONENT (CC)

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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