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EUDAMED last updated this device on May 6, 2026
88000445DN25314THOGEN SPITZE is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by C-K DENTAL IND.CO.,LTD.. Placed on the EU market in Bulgaria. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
0880004450036630-21-MKR-MF-000022929Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →(01)08800044500366
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.
CW009Sterile
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 Bulgaria; available across 6 countries total.
| Country | On market since | Until |
|---|---|---|
| BulgariaPrimary placement | Jan 1, 2020 | Still on market |
| EL | Jan 1, 2020 | Still on market |
| Italy | Jan 1, 2020 | Still on market |
| Lithuania | Jan 1, 2020 | Still on market |
| Poland | Jan 1, 2020 | Still on market |
| Romania | Jan 1, 2020 | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
A010601CARPULE NEEDLESPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →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.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
KR24/0000049IssuedNotified 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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