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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

10340 — IVDR Class A IVDR by DIESSE Diagnostica…

MD Atlas
DIESSE Diagnostica Senese S.p.A

EUDAMED last updated this device on Nov 23, 2022

10340

803389132VMORIGINAL00NX

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: DIESSE Diagnostica Senese S.p.A
UDI-DI code: 08033891324551
Reference / catalog number: 10340

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View device family (Basic UDI)

Manufacturer information

Organization name: DIESSE Diagnostica Senese S.p.A
SRN: IT-MF-000013311
Manufacturer status: Active

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86050/12803389132CHORUSBGG004DOn the market 86050803389132CHORUSBGG004DOn the market 86052803389132CHORUSBGM005BOn the market 86052/12803389132CHORUSBGM005BOn the market 26001803389132AUTODAT2005YOn 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

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

CW010
EUDAMED did not publish a description for this code.
CW018
EUDAMED did not publish a description for this code.

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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: 08033891324551
Basic UDI-DI: 803389132VMORIGINAL00NX
Reference / catalog number: 10340
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: 1
Additional product description: The VES MATIC Original is an automated instrument for the quantitative Erythrocyte Sedimentation Rate (ESR) determination with the modified Westergren method using venous whole blood anticoagulated in citrate. ESR is a non-specific parameter of inflammatory status used as an aid for monitoring the physiological or pathological state of the patient. The instrument is to be used only by professional laboratory users.
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)08033891324551

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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.

W02029001ERYTHROCYTE SEDIMENTATION RATE DEVICES

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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