- Organization name
- UDI-DI code
- Reference / catalog number
IT-MF-000028795PRINTER RESIN SURGICAL GUIDE TRANSPA is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Zirkonzahn SRL. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on May 23, 2026
++D8003DRESSURGGUIDE016TPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
D800ZBAC61xxTRA0
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA / IFA support is coming.
8 warnings recorded — scroll inside the panel to see all entries.
OTHER
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.
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 Italy; available across 32 countries total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | Jul 22, 2025 | Still on market |
| Austria | Jul 22, 2025 | Still on market |
| Belgium | Jul 22, 2025 | Still on market |
| Bulgaria | Jul 22, 2025 | Still on market |
| Cyprus | Jul 22, 2025 | Still on market |
| Czechia | Jul 22, 2025 | Still on market |
| Germany | Jul 22, 2025 | Still on market |
| Denmark | Jul 22, 2025 | Still on market |
| Estonia | Jul 22, 2025 | Still on market |
| EL | Jul 22, 2025 | Still on market |
| Spain | Jul 22, 2025 | Still on market |
| Finland | Jul 22, 2025 | Still on market |
| France | Jul 22, 2025 | Still on market |
| Croatia | Jul 22, 2025 | Still on market |
| Hungary | Jul 22, 2025 | Still on market |
| Ireland | Jul 22, 2025 | Still on market |
| Iceland | Jul 22, 2025 | Still on market |
| Liechtenstein | Jul 22, 2025 | Still on market |
| Lithuania | Jul 22, 2025 | Still on market |
| Luxembourg | Jul 22, 2025 | Still on market |
| Latvia | — | Still on market |
| Malta | Jul 22, 2025 | Still on market |
| Netherlands | Jul 22, 2025 | Still on market |
| Norway | Jul 22, 2025 | Still on market |
| Poland | Jul 22, 2025 | Still on market |
| Portugal | Jul 22, 2025 | Still on market |
| Romania | Jul 22, 2025 | Still on market |
| Sweden | Jul 22, 2025 | Still on market |
| Slovenia | Jul 22, 2025 | Still on market |
| Slovakia | Jul 22, 2025 | Still on market |
| Türkiye | — | Still on market |
| XI | Jul 22, 2025 | 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.
D800ZBAC61xxTRA0Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
++D8003DRESSURGGUIDE016TZBAC61xxTRAUDI 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.
Q0102050199DENTISTRY RESINS - OTHER++D8003DRESDENTTTEMP01PCOn the marketPRINTER RESIN PROVISIONAL TEMPORARY++D8003DRESPROVTEMP01X4On the marketPRINTER RESIN PROVISIONAL TEMPORARY++D8003DRESPROVTEMP01X4On the marketPRINTER RESIN SURGICAL GUIDE TRANSPA++D8003DRESSURGGUIDE016TOn the marketPRINTER RESIN TRY-IN & BURNOUT WHITE++D8003DRESTRYBURN01S9On the marketPRINTER RESIN TRY-IN & BURNOUT WHITE++D8003DRESTRYBURN01S9On the marketNo certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
207/MDRSupplementedNotified 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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