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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

3939/4 — IVDR Class A IVDR by GIESSE DIAGNOSTICS SRL

MD Atlas
GIESSE DIAGNOSTICS SRL

EUDAMED last updated this device on Apr 14, 2026

3939/4

805317297HIT0018L

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: GIESSE DIAGNOSTICS SRL
UDI-DI code: 08053172972530
Reference / catalog number: 3939/4

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Manufacturer information

Organization name: GIESSE DIAGNOSTICS SRL
SRN: IT-MF-000039031
Manufacturer status: Active

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Critical warnings

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

CW085
EUDAMED did not publish a description for this code.
CW082
EUDAMED did not publish a description for this code.
CW162
EUDAMED did not publish a description for this code.
CW167
EUDAMED did not publish a description for this code.
CW422
EUDAMED did not publish a description for this code.
CW305
EUDAMED did not publish a description for this code.

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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: 08053172972530
Basic UDI-DI: 805317297HIT0018L
Reference / catalog number: 3939/4
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: Hitergent is an additive to reaction bath to reduce surface tension on Roche/Hitachi systems.
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

EMDN nomenclature code(s)

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

W0599IVD GENERAL USE CONSUMABLE DEVICES - 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.