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US-MF-000009385Dako Proteinase K Ready-to-use is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. 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 May 26, 2026
570057P3007P3010A053601P4Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)05700571104644
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.
CW010CW011Sterile
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.
05700571104644Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
570057P3007P3010A053601P4S3020UDI 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.
W01030708STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)No certificate specifically references this device's Basic UDI-DI.
570057P3007P3010A056601PROn the marketDako Omnis Vial with Mixing Ball, 2 mL570057P3007P3010A056701PWOn the marketDako Proteinase K Ready-to-use570057P3007P3010A053601P4On the marketDako Target Retrieval Solution (10x)570057P3007P3010A053001N6On the marketDako Wash Buffer 10x570057P3007P3010A053501NXOn the marketEnvision FLEX DAB Enhancer (Dako Omnis)570057P3007P3010A029401P3On the marketNo 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.