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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

TomoCon GO 4.0 — Class IIa MDR by TatraMed Software s.r.o.

MD Atlas
TatraMed Software s.r.o.

EUDAMED last updated this device on Apr 24, 2025

TomoCon GO 4.0

8588008910-TomoConGO-DA

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: TatraMed Software s.r.o.
UDI-DI code: 08588008910047
Reference / catalog number: TomoCon GO 4.0

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View device family (Basic UDI)

Manufacturer information

Organization name: TatraMed Software s.r.o.
SRN: SK-MF-000017681
Manufacturer status: Active

Related devices

RTmedes - Build: 1.6.21168.18588008910-RTmedes-PAOn the market TomoCon GOB-TGO-2-ENOn the market TomoCon GO 3.08588008910-TomoConGO-DAOn the market TomoCon GO 5.08588008910-TomoConGO-DAOn the market TomoCon PACS & Diagnostic stationsB-TomoCon-GLOn the market

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Slovakia; available across 1 country total.

Country	On market since	Until
SlovakiaPrimary placement	Oct 15, 2024	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08588008910047
Basic UDI-DI: 8588008910-TomoConGO-DA
Reference / catalog number: TomoCon GO 4.0
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: —
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)08588008910047

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

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

Z11069005DIAGNOSTIC IMAGING WORKSTATIONS

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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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.