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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

016 — Class IIa MDR by DeepTrace Technologies…

MD Atlas
DeepTrace Technologies S.R.L.

EUDAMED last updated this device on May 28, 2026

016

805201514TRACE4OCv2.175

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: DeepTrace Technologies S.R.L.
UDI-DI code: 08052015140167
Reference / catalog number: 016

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View device family (Basic UDI)

Manufacturer information

Organization name: DeepTrace Technologies S.R.L.
SRN: IT-MF-000027591
Manufacturer status: Active

Related devices

014, 031B-TRACE4ADU7On the market 019805201514TRACE4ADCLv2.52ZOn the market 021805201514TRACE4BUSv2.1E3On the market 002B-TRACE4OCVFOn the market

Certificates

Certificate health across this manufacturer's portfolio.

ITH 2412063 1Issued
Quality management systemNotified body: 1936Expiry: Feb 17, 2030

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	May 22, 2026	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08052015140167
Basic UDI-DI: 805201514TRACE4OCv2.175
Reference / catalog number: 016
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: https://www.deeptracetech.com/en/products/trace4oc
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)08052015140167

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EMDN nomenclature code(s)

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

Z11069082VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES

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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