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Organization name
UDI-DI code
Reference / catalog number

Potassium Electrode (K+) — IVDR Class B IVDR by VitalScientific

MD Atlas
VitalScientific

EUDAMED last updated this device on Jul 11, 2025

Potassium Electrode (K+)

370170083918-00507ZH

On the marketIVDR Class B

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: VitalScientific
UDI-DI code: 03701700828136
Reference / catalog number: 3918-005

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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 10, 2024	Still on market

Device identification

Trade name: Potassium Electrode (K+)
UDI-DI code: 03701700828136
Basic UDI-DI: 370170083918-00507ZH
Reference / catalog number: 3918-005
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: "The ISE measurement system is to be used on Selectra analyzers equipped with an ISE module for the quantitative determination of sodium (Na+), potassium (K+), chloride (Cl-) and total CO2, in human serum and plasma. These in vitro diagnostic devices are 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)

W0101070106POTASSIUM - ELECTRODES

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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