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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

IV Screen — Class IIa MDR by Monidor Oy

MD Atlas
Monidor Oy

EUDAMED last updated this device on Oct 21, 2024

IV Screen

643006695V0046S

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Monidor Oy
UDI-DI code: 06430066950041
Reference / catalog number: V004456

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Manufacturer information

Organization name: Monidor Oy
SRN: FI-MF-000007941
Manufacturer status: Active

Market distribution

Primary placement in Finland; available across 1 country total.

Country	On market since	Until
FinlandPrimary placement	Nov 1, 2020	Still on market

Device identification

Trade name: IV Screen
UDI-DI code: 06430066950041
Basic UDI-DI: 643006695V0046S
Reference / catalog number: V004456
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: IV Screen is a cloud SW application. IV infusion monitors (e.g. Monidrop® W) connect to the IV Screen cloud application and send infusion and device data to it and receive some infusion related reference values from IV Screen.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12030392INFUSION INSTRUMENTS - MEDICAL DEVICE SOFTWARE

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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

V017456643006695V01773On the market Monidrop W643006695V0006JOn 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.