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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

08003 — Class IIa MDR by Eco3 S.r.l.

MD Atlas
Eco3 S.r.l.

EUDAMED last updated this device on Jan 9, 2026

08003

805620936SERIE_EUE

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Eco3 S.r.l.
UDI-DI code: 08056209360089
Reference / catalog number: 08003

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View device family (Basic UDI)

Manufacturer information

Organization name: Eco3 S.r.l.
SRN: IT-MF-000027945
Manufacturer status: Active

Critical warnings

4 warnings recorded — scroll inside the panel to see all entries.

CW999
Se inalato, l'ozono è un gas tossico, la soglia di percezione per l'essere umano è a 0,02-0,05 mg/l, molto inferiore alla concentrazione massima sopportabile.
CW999
Controindicazioni: favismo, ipertiroidismo, donne in stato di gravidanza, carenza di G6PD, piastrino penici, cachettici o predisposti a reazioni di ipersensibilità, età inferiore a 18 anni.
CW010
EUDAMED did not publish a description for this code.
CW999
L'ozono è un gas molto reattivo, il contatto con etere, suoi derivati o fluidi combustibili può causare detonazioni.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08056209360089
Basic UDI-DI: 805620936SERIE_EUE
Reference / catalog number: 08003
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)08056209360089

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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.

Z12040207OZONE THERAPY EQUIPMENT

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

01003805620936SERIE_EUEOn the market 03003805620936SERIE_EUEOn the market

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.