- Role
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- Date of registration
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EUDAMED last updated this device on Aug 16, 2023
4046681152337WSpH-Fix 4.5 - 10.0 PT is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class B. Manufactured by MACHEREY-NAGEL GmbH & Co. KG. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
0404668100362292121DE-MF-000005636IX 1038121-1(01)04046681003622
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
2 warnings recorded — scroll inside the panel to see all entries.
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
Primary placement in Germany; available across 9 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Aug 16, 2023 | Still on market |
| Austria | Aug 16, 2023 | Still on market |
| Cyprus | Aug 16, 2023 | Still on market |
| Spain | Aug 16, 2023 | Still on market |
| France | Aug 16, 2023 | Still on market |
| Croatia | Aug 16, 2023 | Still on market |
| Ireland | Aug 16, 2023 | Still on market |
| Luxembourg | Aug 16, 2023 | Still on market |
| Malta | Aug 16, 2023 | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
W01010699CLIN. CHEM. RT & POC - OTHERPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →IVDR risk classes
IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Certificate health across this manufacturer's portfolio.
IX 1038121-2IssuedIX 1038121-3IssuedIX 1038121-4IssuedHX 1038121-1IssuedIX 1038121-1IssuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →Notified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →Notified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →Notified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →Notified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →