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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

120436 — Class IIb MDR by Tieto Finland Oy

MD Atlas
Tieto Finland Oy

EUDAMED last updated this device on May 29, 2024

120436

643007665AABE9

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Tieto Finland Oy
UDI-DI code: 06430076650184
Reference / catalog number: 120436

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Manufacturer information

Organization name: Tieto Finland Oy
SRN: FI-MF-000002445
Manufacturer status: Active

Market distribution

Primary placement in Finland; available across 1 country total.

Country	On market since	Until
FinlandPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 06430076650184
Basic UDI-DI: 643007665AABE9
Reference / catalog number: 120436
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12040192GENERAL MEDICINE DIAGNOSIS AND MONITORING 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-03-1226-911-26Supplemented
Quality management systemNotified body: 0537Expiry: Aug 11, 2028