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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

EVO.1064 — Class IIb MDD by Project Blue Generation…

MD Atlas
Project Blue Generation s.r.l.

EUDAMED last updated this device on Apr 28, 2026

EVO.1064

B-08055719580079

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Project Blue Generation s.r.l.
UDI-DI code: 08055719580079
Reference / catalog number: EVO.1064

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View device family (Basic UDI)

Manufacturer information

Organization name: Project Blue Generation s.r.l.
SRN: IT-MF-000027914
Manufacturer status: Active

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 Italy; available across 3 countries total.

Country	On market since	Until
ItalyPrimary placement		Still on market
Croatia		Still on market
Poland		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08055719580079
Basic UDI-DI: B-08055719580079
Reference / catalog number: EVO.1064
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDD [Directive 93/42/EEC 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)08055719580079

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EMDN nomenclature code(s)

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

Z120615THERAPEUTIC LASERS

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

This device is not currently linked to any other device.

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.