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EUDAMED last updated this device on Jun 20, 2025
B-10840326422080Cefla CE153 Pro-Tip Converter Kit Astek is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Young Innovations Inc. Placed on the EU market in Ireland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
10840326422080116346ASTEK(01)10840326422080
European Medical Device Nomenclature — the EU product classification assigned to this device.
Q0199ODONTOLOGY DEVICES - OTHERUS-MF-0000177960425-MED-004439Primary placement in Ireland; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| IrelandPrimary placement | Sep 29, 2020 | Still on market |
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.
View in glossary →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.
View in glossary →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
View in glossary →Primary 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 →Primary 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 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.0843471116350D36733EHYDXOn the marketBite Trays Sideless Posterior (50 pcs) - Unodent0843471116350D36733EHYDXOn the marketCastellini CA152 Converter Kit CeflaB-10843471151546On the marketCefla CE153 Pro-Tip Converter Kit CeflaB-10840326422097On the marketCONVERSION KIT CEFLA ANTHOS F3/F6B-10843471135027On the marketCONVERSION KIT CEFLA SPB-10843471135034On the marketNo certificate specifically references this device's Basic UDI-DI.