- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on Mar 8, 2024
590761904012EQPolyester Tape, Polyester Matrix Bands, tooth-shaped box, 8/0.050mm, 15m 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-000001898No 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.(01)05907619041903
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.
05907619041903Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
590761904012EQ1145UDI 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 →No certificate specifically references this device's Basic UDI-DI.
590761904012EQOn the marketPolyester Tape, Polyester Matrix Band, tooth-shaped box, 8/0.075mm, 15m590761904012EQOn the marketPolyester Tape, Polyester Matrix Bands, tooth-shaped box, 10/0.075mm, 15m590761904012EQOn the marketPolyester Tape, Polyester Matrix Bands, tooth-shaped box, size 8/0.036mm, 15m590761904012EQOn the marketSectional Metal Matrices SET 180 pcs590761904018F4On the marketSectional Metal Matrices with Tab SET 180 pcs590761904018F4On the market