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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

DIAMOND 2 — IVDR Class A IVDR by Tridema Engineering srl

MD Atlas
Tridema Engineering srl

EUDAMED last updated this device on May 18, 2026

DIAMOND 2

805792056Diamond2GB

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Tridema Engineering srl
UDI-DI code: 08057920560024
Reference / catalog number: DIAM2014

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View device family (Basic UDI)

Manufacturer information

Organization name: Tridema Engineering srl
SRN: IT-MF-000054318
Manufacturer status: Active

Critical warnings

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

CW010
Consult the instructions for use before operation, cleaning, service and maintenance. Observe precautions for handling potentially infectious biological samples and waste materials.

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Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	May 29, 2025	Dec 31, 2040

Device identification

Trade name: DIAMOND 2
UDI-DI code: 08057920560024
Basic UDI-DI: 805792056Diamond2GB
Reference / catalog number: DIAM2014
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: 2-channel semi-automatic coagulometer intended for professional use in laboratories for performing coagulation tests on biological samples.
Additional information URL: https://www.tridema.it/---ivd.html
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)08057920560024

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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.

W0202020101SEMI-AUTOMATED COAGULOMETERS

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.