Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Partners Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

Neat LX - Latex Removal 27 mL — IVDR Class A IVDR

MD Atlas
Edif Instruments S.r.l.

EUDAMED last updated this device on Oct 19, 2023

Neat LX - Latex Removal 27 mL

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: 80536089442548
Reference / catalog number: FOE08009E-027B

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

View device family (Basic UDI)

Manufacturer information

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

Related devices

Reaction segment with 24 wells (Single-use)805360894CML07075H6On the market Adapter for CML07022A-001A cups on 12mm position805360894ACC07028/29/33D8On the market Adapter for CML07026A-001A / CML07013A-001A reagent bottles805360894ACC07028/29/33D8On the market Alcor805360894ES000024VOn the market Alcor - Automated Immunochemistry Analyser805360894ES000024VOn 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

No critical warnings reported for this device.

EasyUDICompliance engine

Sponsored

Your devices, UDI-compliant — without drowning in regulation

EUDAMED-ready· UDI-enriched

Basic UDIUDI-DIUDI-PIAttributeDocument

Print-ready label

From your product file — no manual entry

Exclusive to MD Atlas usersClaim my −20% discount

by Made In Tracker

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: Neat LX - Latex Removal 27 mL
UDI-DI code: 80536089442548
Basic UDI-DI: 805360894KIT08009NU
Reference / catalog number: FOE08009E-027B
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: 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, and as an extra wash of the same cuvettes.
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)80536089442548

Sign in to download the DataMatrix

Create a free account to download the UDI-DI DataMatrix for this device.

Email

Password

No account yet?

UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

Sign in to generate the UDI-PI DataMatrix

Create a free account, then generate the compliant UDI-PI carrier for this device.

Email

Password

No account yet?

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

Become a partner of MD Atlas