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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

YC500009 — IVDR Class A IVDR by Technogenetics S.p.A

MD Atlas
Technogenetics S.p.A

EUDAMED last updated this device on Oct 26, 2022

YC500009

805432095DSORBAU

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: 08054320950981
Reference / catalog number: YC500009

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View device family (Basic UDI)

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

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

CW265
D-Sorb Solution contains NaOH at 0.12% concentration (that is, below the 0.5% limit for classifying a preparation as irritant) but must nevertheless be handled using the appropriate personal protective equipment normally used for handling diagnostic kits in order to ensure that the preparation does not come into contact with skin and/or eyes.
CW011
This product must be used by professional users only and in strict accordance with the instructions set out in this document.

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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: 08054320950981
Basic UDI-DI: 805432095DSORBAU
Reference / catalog number: YC500009
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: D-Sorb Solution is used for washing and decontaminating the dispensing tip of the TGS TA Analyzer instrument. D-Sorb Solution can be used in conjunction with all the specific and common reagents needed for performing assays with the TGS TA Analyzer. D-Sorb Solution may be used in conjunction any reagent, regardless of lot number. This product must be used in strict compliance with the instructions given in this document by professional users
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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