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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

BVS100H — IVDR Class A IVDR by BIOSIGMA S.P.A.

MD Atlas
BIOSIGMA S.P.A.

EUDAMED last updated this device on Mar 24, 2026

BVS100H

803367356URINALYSISX2

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: BIOSIGMA S.P.A.
UDI-DI code: 08033673568715
Reference / catalog number: BVS100H

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View device family (Basic UDI)

Manufacturer information

Organization name: BIOSIGMA S.P.A.
SRN: IT-MF-000030370
Manufacturer status: Active

Related devices

BVS1719803367356URINALYSISX2On the market BVS171803367356URINALYSISX2On the market BVS1715803367356URINALYSISX2On the market BVS101803367356URINALYSISX2On the market 4242803367356URINALYSISX2On 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.

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

Device identification

Trade name: not provided
UDI-DI code: 08033673568715
Basic UDI-DI: 803367356URINALYSISX2
Reference / catalog number: BVS100H
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 100
Additional product description: disposable devices intended for use in the laboratory for the standardized analysis of urine sediment samples.
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)08033673568715

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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.

W05039099DEVICES FOR SAMPLES ANALYSES - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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