- Role
- Country
- Date of registration
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PL-MF-000052302No 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.Filling instrument double-ended ball 2,0 x 2,5 mm is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Fabryka Narzędzi Medycznych Chirmed Marcin Dyner Spółka Komandytowa. Placed on the EU market in Poland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Mar 10, 2026
59041514DF01G9Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)05904151418439
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.
Products made of stainless steel contain metals (in the form of alloying additives or in trace amounts) that may cause allergies (Nickel, Chromium, Cobalt). The product is contraindicated for people with allergies to any component of steel.
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.
05904151418439Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
59041514DF01G9ST 1003UDI 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.
Q01010299ROOT CANAL FILLING DEVICES - OTHER59041514DF01G9On the marketFilling instrument double-ended ball 1,6 x 2,0 mm59041514DF01G9On the marketFilling instrument double-ended ball 1,6 x 2,5 mm59041514DF01G9On the marketFilling instrument double-ended ball 2,6 x 3,0 mm59041514DF01G9On the marketFilling instrument double-ended ball 2,7 x 3,2 mm59041514DF01G9On the marketFilling instrument double-ended ball 2,9 x 3,6 mm59041514DF01G9On the marketNo certificate specifically references this device's Basic UDI-DI.