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EUDAMED last updated this device on May 14, 2025
590761904001EKArt.11-95 Polyester Crown Forms, Upper Incisor Central, size 95, Right, 5pcs is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by AnGer G&A Przedsiębiorstwo Produkcyjne. Placed on the EU market in Poland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
PL-MF-000001898(01)05907619040142
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
4 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.
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 Poland; available across 1 country total.
Placed on the market in Poland; per-country availability dates not published.
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
05907619040142Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
590761904001EK11-95UDI 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.
Q01010401PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRYPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →590761904001EKOn the marketArt.11-85 Polyester Crown Forms, Upper Incisor Central, size 85, Right, 5pcs590761904001EKOn the marketArt.11-90 Polyester Crown Forms, Upper Incisor Central, size 90, Right, 5pcs590761904001EKOn the marketArt.11&21-100 Polyester Crown Forms, Upper Incisors Central, size 100, 10pcs590761904001EKOn the marketArt.11&21-105 Polyester Crown Forms, Upper Incisors Central, size 105, 10pcs590761904001EKOn the marketArt.11&21-110 Polyester Crown Forms, Upper Incisors Central, size 110, 10pcs590761904001EKOn 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.No certificate specifically references this device's Basic UDI-DI.