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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

OMEOVITA FAST THERAPY… — Class I MDR by UNION COSMETICS SRL

MD Atlas
UNION COSMETICS SRL

EUDAMED last updated this device on Apr 8, 2025

OMEOVITA FAST THERAPY PARABEN-FREE DIATHERMY CREAM 1000ML

805116083CRDTR6K

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: UNION COSMETICS SRL
UDI-DI code: 08051160834891
Reference / catalog number: OM891

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View device family (Basic UDI)

Manufacturer information

Organization name: UNION COSMETICS SRL
SRN: IT-MF-000043859
Manufacturer status: Active

Critical warnings

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

CW032
non utilizzare dopo la data di scadenza
CW999
do not use in pregnant women, people with active neoplasms, and people with pacemakers - do not ingest - keep out of reach of children

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Market distribution

Primary placement in Italy; available across 1 country total.

Placed on the market in Italy; per-country availability dates not published.

Device identification

Trade name: OMEOVITA FAST THERAPY PARABEN-FREE DIATHERMY CREAM 1000ML
UDI-DI code: 08051160834891
Basic UDI-DI: 805116083CRDTR6K
Reference / catalog number: OM891
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: 1000 MU03

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08051160834891

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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.

V9015ELECTRODES AND PROBES CUTANEOUS CONDUCTIVE SUBSTANCES

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.