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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

AL700002 — IVDR Class A IVDR by Technogenetics S.p.A

MD Atlas
Technogenetics S.p.A

EUDAMED last updated this device on Oct 26, 2022

AL700002

805432095AL1200SYSTEMXA

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Technogenetics S.p.A
UDI-DI code: 08054320951025
Reference / catalog number: AL700002

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View device family (Basic UDI)

Manufacturer information

Organization name: Technogenetics S.p.A
SRN: IT-MF-000025331
Manufacturer status: Active

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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.

Critical warnings

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

CW265
These reagents contain sodium azide <0.09% (w/w) which may react with lead, cooper, or brass plumbing to form highly explosive metal azides. On disposal, flush with large volumes of water to prevent azide build up.
CW011
The AL1200 System Liquid is for in vitro diagnostic use only and is not for internal use in humans or animals. Technogenetics will not be held responsible for any loss or damage (except as required by statute) howsoever caused, arising out of non-compliance with the instructions provided.

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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: 08054320951025
Basic UDI-DI: 805432095AL1200SYSTEMXA
Reference / catalog number: AL700002
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: System Liquid (AL1200 SL) is an in vitro diagnostic device intended to be used on the automated AL1200 analyser. It is a solution for priming and cleaning the fluidic parts of the AL1200 analyser during operation. System Liquid is used in conjunction with all AL1200 assay reagents.
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.

W01029099IMMUNOCHEMISTRY REAGENTS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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