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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

V017456 — Class IIb MDR by Monidor Oy

MD Atlas
Monidor Oy

EUDAMED last updated this device on Oct 21, 2024

V017456

643006695V01773

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Monidor Oy
UDI-DI code: 06430066950171
Reference / catalog number: V017456

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Manufacturer information

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

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 Finland; available across 1 country total.

Country	On market since	Until
FinlandPrimary placement	Jan 1, 2025	Still on market

Device identification

Trade name: not provided
UDI-DI code: 06430066950171
Basic UDI-DI: 643006695V01773
Reference / catalog number: V017456
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Remote monitoring software for periodic SpO₂ and pulse value tracking for wards and home hospital care
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12030692VITAL SIGNS TELEMETRY 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

IV Screen643006695V0046SOn 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.