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Organization name
UDI-DI code
Reference / catalog number

Merlot Medi Physio v3.1 — Class IIb MDR by CGI Suomi Oy

MD Atlas
CGI Suomi Oy

EUDAMED last updated this device on Mar 5, 2025

Merlot Medi Physio v3.1

643007895MMPHYSIO01QL

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: CGI Suomi Oy
UDI-DI code: 06430078950022
Reference / catalog number: Merlot Medi Physio v3.1

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Manufacturer information

Organization name: CGI Suomi Oy
SRN: FI-MF-000012661
Manufacturer status: Active

Market distribution

Primary placement in Finland; available across 1 country total.

Country	On market since	Until
FinlandPrimary placement	Mar 5, 2025	Still on market

Device identification

Trade name: not provided
UDI-DI code: 06430078950022
Basic UDI-DI: 643007895MMPHYSIO01QL
Reference / catalog number: Merlot Medi Physio v3.1
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: Merlot Medi Physio software is part of Merlot Medi solution. Merlot Medi Physio software is used in emergency medical care to document patient care information and view documented information.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12040292GENERAL MEDICINE THERAPEUTIC TREATMENT 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

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Certificates

Certificate health across this manufacturer's portfolio.

CR-03-1156-859-24Supplemented
Quality management systemNotified body: 0537Expiry: Dec 9, 2029