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US-MF-000009385FLEX Monoclonal Rabbit Anti-Human Cytokeratin 8/18, Clone EP17/EP30, Ready-to-Use (Dako Omnis) is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class C. Manufactured by Agilent Technologies, Inc.. Placed on the EU market in Denmark. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Aug 4, 2026
570057R0301P3007C072401P7Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)05700575011030
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
3 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 Denmark; available across 32 countries total.
| Country | On market since | Until |
|---|---|---|
| DenmarkPrimary placement | — | Still on market |
| Austria | — | Still on market |
| Belgium | — | Still on market |
| Bulgaria | — | Still on market |
| Cyprus | — | Still on market |
| Czechia | — | Still on market |
| Germany | — | Still on market |
| Estonia | — | Still on market |
| EL | — | Still on market |
| Spain | — | Still on market |
| Finland | — | Still on market |
| France | — | Still on market |
| Croatia | — | Still on market |
| Hungary | — | Still on market |
| Ireland | — | Still on market |
| Iceland | — | Still on market |
| Italy | — | Still on market |
| Liechtenstein | — | Still on market |
| Lithuania | — | Still on market |
| Luxembourg | — | Still on market |
| Latvia | — | Still on market |
| Malta | — | Still on market |
| Netherlands | — | Still on market |
| Norway | — | Still on market |
| Poland | — | Still on market |
| Portugal | — | Still on market |
| Romania | — | Still on market |
| Sweden | — | Still on market |
| Slovenia | — | Still on market |
| Slovakia | — | Still on market |
| Türkiye | — | Still on market |
| XI | — | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
05700575011030Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
570057R0301P3007C072401P7GA09461-2UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
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.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0102030199CANCER ANTIGENS - OTHER570057R0301P3007C086401QEOn the marketFLEX Monoclonal Mouse Anti-Human Napsin A, Clone DAK-NapA, Ready-to-Use (Dako Omnis)570057R0301P3007C086201Q4On the marketFLEX Monoclonal Mouse Anti-Human Podoplanin, Clone D2-40, Ready-to-Use (Dako Omnis)570057R0301P3007C071701PFOn the marketFLEX Monoclonal Rabbit Anti-Human PAX8, Clone DAK-PAX8, Ready-to-Use (Dako Omnis)570057R0301P3007C070301NLOn the marketFLEX Monoclonal Rabbit Anti-Human Terminal Deoxynucleotidyl Transferase, Clone EP266, Ready-to-Use (Dako Omnis)570057R0301P3007C072301P2On the marketFLEX Monoclonal Rabbit Anti-Human TTF-1, Clone DAK-TTF-1, Ready-to-Use (Dako Omnis)570057R0301P3007C086001PSOn the marketNo certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
V75 113968 0006SupplementedNotified 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.
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