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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

OMNIK — Class I MDR by Gruppo Industriale…

MD Atlas
Gruppo Industriale Formenti S.a.s.

EUDAMED last updated this device on Apr 22, 2026

OMNIK

803264602TPMATCD

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Gruppo Industriale Formenti S.a.s.
UDI-DI code: 08032646021608
Reference / catalog number: OMNIK

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View device family (Basic UDI)

Manufacturer information

Organization name: Gruppo Industriale Formenti S.a.s.
SRN: IT-MF-000050869
Manufacturer status: Active

Related devices

GUDOM803264602TPGUAC5On the market GUDUE803264602TPGUAC5On the market GUF11803264602TPGUAC5On the market GUF13803264602TPGUAC5On the market GUIDM803264602TPGUAC5On 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.

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		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08032646021608
Basic UDI-DI: 803264602TPMATCD
Reference / catalog number: OMNIK
Issuing entity: GS1

Classification

Risk category: Class I
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: 50–240 MU10
150–240 MU10

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08032646021608

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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.

V080702NON ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES

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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