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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

AL800001 — IVDR Class A IVDR by Technogenetics S.p.A

MD Atlas
Technogenetics S.p.A

EUDAMED last updated this device on Oct 26, 2022

AL800001

805432095AL1200ANALYZER72

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: 08054320951032
Reference / catalog number: AL800001

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Manufacturer information

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

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

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

CW008
Inappropriately handling samples may lead to biohazardous infection. Do not touch the sample, control liquid, calibrators, mixture and waste liquids directly with your hands. Wear gloves and lab coat, if necessary, goggles as well during operation. Please, refer to the Safety and Data Sheet for each type of products. In case your skin contacts the sample, control liquid or calibrator etc. please follow standard laboratory safety procedure and consult a doctor.
CW273
When the MAIN POWER is on, non-authorized personnel must not open the rear cover or side cover of the instrument. Spillage of reagent or sample on the analyzer may cause equipment failure and even electric shock. Do not place sample and reagent or other liquids on the analyzer. In case of spillage, switch off the power immediately, remove the spillage and contact Customer Service Department of Technogenetics. When two switches in the left side of this equipment are off, inside power cables still connect with outside power. Only after switching off MAIN POWER, the risk of electric shock from AC power will not be exist
CW011
When the system is running, any part of the body, clothing or hair must be kept away from moving parts.

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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: 08054320951032
Basic UDI-DI: 805432095AL1200ANALYZER72
Reference / catalog number: AL800001
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 AL1200 is an automated chemiluminescence analyzer for in vitro assays in clinical biology and autoimmunity that performs the sample processing (sample pre-dilution, sample and reagent dispensing, incubation, washing procedure), as well as measurement and interpretation of results
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.

W0201020102AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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