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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

GAF003000B1 — IVDR Class A IVDR by ADDAX BIOSCIENCES S.R.L.

MD Atlas
ADDAX BIOSCIENCES S.R.L.

EUDAMED last updated this device on Jan 23, 2026

GAF003000B1

805797751GAF001CS

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: ADDAX BIOSCIENCES S.R.L.
UDI-DI code: 08057977510089
Reference / catalog number: GAF003000B1

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View device family (Basic UDI)

Manufacturer information

Organization name: ADDAX BIOSCIENCES S.R.L.
SRN: IT-MF-000028891
Manufacturer status: Active

Related devices

GAF001000B1805797751GAF001CSOn the market GAF010000B1805797751GAF001CSOn the market GAF000010P40805797751GAF001CSOn the market GAF000125P24805797751GAF001CSOn the market GAF000025P40805797751GAF001CSOn 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

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

CW167
EUDAMED did not publish a description for this code.
CW422
EUDAMED did not publish a description for this code.
CW306
EUDAMED did not publish a description for this code.
CW129
Contains glyoxal. May cause an allergic skin reaction.

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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: 08057977510089
Basic UDI-DI: 805797751GAF001CS
Reference / catalog number: GAF003000B1
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: —
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)08057977510089

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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.

W01030705FIXING REAGENTS (HISTOLOGY/CYTOLOGY)

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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