- Role
- Country
- Date of registration
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CZ-MF-000032589Dentapreg® PFU Refill is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by ADM, a.s.. Placed on the EU market in Czechia. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Sep 2, 2025
85956527PFU9JPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)08595652700054
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
1 warning recorded — scroll inside the panel to see all entries.
CW011Sterile
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.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in Czechia; available across 32 countries total.
| Country | On market since | Until |
|---|---|---|
| CzechiaPrimary placement | Apr 1, 2004 | Still on market |
| Austria | — | Still on market |
| Belgium | — | Still on market |
| Bulgaria | Apr 1, 2004 | Still on market |
| Cyprus | — | Still on market |
| Germany | Apr 1, 2004 | Still on market |
| Denmark | Apr 1, 2004 | Still on market |
| Estonia | — | Still on market |
| EL | — | Still on market |
| Spain | Apr 1, 2004 | Still on market |
| Finland | Apr 1, 2004 | Still on market |
| France | Apr 1, 2004 | Still on market |
| Croatia | — | Still on market |
| Hungary | Apr 1, 2004 | Still on market |
| Ireland | — | Still on market |
| Iceland | — | Still on market |
| Italy | Apr 1, 2004 | Still on market |
| Liechtenstein | — | Still on market |
| Lithuania | Apr 1, 2004 | Still on market |
| Luxembourg | — | Still on market |
| Latvia | Apr 1, 2004 | Still on market |
| Malta | — | Still on market |
| Netherlands | — | Still on market |
| Norway | — | Still on market |
| Poland | Apr 1, 2004 | Still on market |
| Portugal | — | Still on market |
| Romania | Apr 1, 2004 | Still on market |
| Sweden | — | Still on market |
| Slovenia | — | Still on market |
| Slovakia | Apr 1, 2004 | Still on market |
| Türkiye | Apr 1, 2004 | 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.
08595652700054Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
85956527PFU9JD-003UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
European Medical Device Nomenclature — the EU product classification assigned to this device.
Q010299PROSTHETIC DENTISTRY DEVICES - OTHERNo certificate specifically references this device's Basic UDI-DI.
85956527PFU9JOn the marketDentapreg® PFU Minirefill85956527PFU9JOn the marketDentapreg® PFU Posterior Bridge85956527PFU9JOn the marketDentapreg® PFU Sample85956527PFU9JOn the marketDentapreg® PFU Sample Clin85956527PFU9JOn the marketDentapreg® PFU Single85956527PFU9JOn the marketCertificate health across this manufacturer's portfolio.
25 0302 QR/NBIssuedNotified 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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