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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

133455 — Class IIb MDR by Tietoevry Sweden AB

MD Atlas
Tietoevry Sweden AB

EUDAMED last updated this device on Nov 16, 2023

133455

643007665AACEB

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Tietoevry Sweden AB
UDI-DI code: 06430076650023
Reference / catalog number: 133455

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View device family (Basic UDI)

Manufacturer information

Organization name: Tietoevry Sweden AB
SRN: SE-MF-000037728
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Sweden; available across 1 country total.

Country	On market since	Until
SwedenPrimary placement	Nov 28, 2012	Still on market

Device identification

Trade name: not provided
UDI-DI code: 06430076650023
Basic UDI-DI: 643007665AACEB
Reference / catalog number: 133455
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.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)06430076650023

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

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

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Related devices

NCS Cross643007665AACEBOn the market

Certificates

Certificate health across this manufacturer's portfolio.

CR-03-1231-829-23Supplemented
Quality management systemNotified body: 0537Expiry: Oct 27, 2028