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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

Tray of Unlabeled Neat LX -… — IVDR Class A IVDR

MD Atlas
Edif Instruments S.r.l.

EUDAMED last updated this device on Oct 19, 2023

Tray of Unlabeled Neat LX - Latex Removal 27 mL (18 bottles)

805360894KIT08009NU

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Edif Instruments S.r.l.
UDI-DI code: 80536089442302
Reference / catalog number: FOE08009E-486B

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View device family (Basic UDI)

Manufacturer information

Organization name: Edif Instruments S.r.l.
SRN: IT-MF-000009556
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

No critical warnings reported for this device.

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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: Tray of Unlabeled Neat LX - Latex Removal 27 mL (18 bottles)
UDI-DI code: 80536089442302
Basic UDI-DI: 805360894KIT08009NU
Reference / catalog number: FOE08009E-486B
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: 18
Additional product description: This washing solution is used to eliminate the adhesion of the latex microspheres to the BIONEX reading cuvettes on automatic analyzers. The solution is used on board the instrument both as a post-injection solution at the end of the reaction, in order to inhibit the bonding of the latex to the surface of the cuvettes, as an extra wash of the same cuvettes. 18x27mL
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

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Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)80536089442302

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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.

W0201010185CHEMISTRY ANALYSERS - CONSUMABLES
W0201020185AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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