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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

FCC217-2 — IVDD — General IVDD by FUTURLAB S.R.L.

MD Atlas
FUTURLAB S.R.L.

EUDAMED last updated this device on Mar 12, 2026

FCC217-2

B-UREA-UV9W

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: FUTURLAB S.R.L.
UDI-DI code: D-UREA-UV9W
Reference / catalog number: FCC217-2

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Manufacturer information

Organization name: FUTURLAB S.R.L.
SRN: IT-MF-000046539
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW011
Contains sodium azide as preservative. Handle according to good laboratory practice.

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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: not provided
UDI-DI code: D-UREA-UV9W
Basic UDI-DI: B-UREA-UV9W
Reference / catalog number: FCC217-2
Issuing entity: EUDAMED

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: The Urea UV Kit is used for the determination of urea in serum, plasma and urine. Kinetic UV urease-GLDH method.
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

D-UREA-UV9W

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

EMDN nomenclature code(s)

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

W01010204UREA/BLOOD UREA NITROGEN

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.