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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

IKIT100OG — IVDD — General IVDD by H & D S.R.L.

MD Atlas
H & D S.R.L.

EUDAMED last updated this device on May 21, 2026

IKIT100OG

B-08050247776758

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: H & D S.R.L.
UDI-DI code: 08050247776758
Reference / catalog number: IKIT100OG

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View device family (Basic UDI)

Manufacturer information

Organization name: H & D S.R.L.
SRN: IT-MF-000036620
Manufacturer status: Active

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: 08050247776758
Basic UDI-DI: B-08050247776758
Reference / catalog number: IKIT100OG
Issuing entity: GS1

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Il test d-ROMs test è undispositivo medico didiagnostica in vitro, per usoprofessionale, impiegato perla determinazione dei radicaliliberi attraverso laquantificazione quantitativadei perossidi in campioni diplasma. Il test può essereeseguito indipendentemente FASE 4 Caratteristiche del dispositivo < Tornare alla fase 4 Stato del dispositivo dallo stato di salute delsoggetto e con diversefinalità: sia di screening, siadi controllo. I risultati fannoriferimento all’identificazionedei perossidi solo in campionisanguigni ottenuti, econservati, secondo lemodalità descritte nelpresente foglietto illustrativo.
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)08050247776758

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EMDN nomenclature code(s)

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

W01019099CLINICAL CHEMISTRY REAGENTS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

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.