Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ 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

NEOS-32 XT Nucleic Acid Extractor… — IVDR Class A IVDR

MD Atlas
Linear Chemicals S.L.U

EUDAMED last updated this device on May 26, 2022

NEOS-32 XT Nucleic Acid Extractor System

843528739530J5

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Linear Chemicals S.L.U
UDI-DI code: 8435287395303
Reference / catalog number: 7310000

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?

Manufacturer information

Organization name: Linear Chemicals S.L.U
SRN: ES-MF-000003284
Manufacturer status: Active

Related devices

iso-Clean 1x500 mL843528737000GMOn the market ALTHEA843528739000H3On the market ALTHEA cleaner solution843528737030GWOn the market 3801055843528739030HCOn the market ARES843528739010H6On 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

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

CW008
Biohazard. Indicate that an area of the instrument is easily contaminated by biological reagents or samples. Please immediately disinfect the area after contamination. At the same time, remind the operator of careful operation, maintain necessary vigilance, and take corresponding protective measures.
CW258
High temperature surface. Indicate the possible high temperature on a surface of the instrument, and remind the operator of being careful about burns during operation.
CW011
Indicate that moving parts in an area of the instrument may cause damage to the user. Remind the user of not opening the experiment cabin during the operation of the instrument.

Market distribution

Primary placement in Spain; available across 1 country total.

Placed on the market in Spain; per-country availability dates not published.

Device identification

Trade name: NEOS-32 XT Nucleic Acid Extractor System
UDI-DI code: 8435287395303
Basic UDI-DI: 843528739530J5
Reference / catalog number: 7310000
Issuing entity: HIBCC

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: NEOS-32 XT Nucleic Acid Extractor System
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W02050116NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification