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DE-MF-000009201G1 049319 0002TESSYS® / iLESSYS® Disposable Access KIT5 is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Joimax GmbH. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on May 21, 2026
B-04250337101093Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)04250337101093
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 Germany; available across 19 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Still on market | |
| Austria | Still on market | |
| Belgium | Still on market | |
| Bulgaria | Still on market | |
| Czechia | Still on market | |
| Denmark | Still on market | |
| EL | Still on market | |
| Spain | Still on market | |
| France | Still on market | |
| Croatia | Still on market | |
| Ireland | Still on market | |
| Italy | Still on market | |
| Luxembourg | Still on market | |
| Netherlands | Still on market | |
| Norway | Still on market | |
| Poland | Still on market | |
| Portugal | Still on market | |
| Romania | Still on market | |
| Türkiye | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
04250337101093Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
B-04250337101093TDAK0050UDI 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.
A01030101SPINAL ANAESTHESIA NEEDLES AND KITSCertificate health across this manufacturer's portfolio.
G10 049319 0007SupplementedG11 049319 0011IssuedNotified 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.
View in glossary →Notified 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.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
42503371CONTHJOn the marketTESSYS® / iLESSYS® Disposable Access KIT2B-04250337101062On the marketTESSYS® / iLESSYS® Disposable Access KIT2 ECOB-04250337104148On the marketTESSYS® Cleaning Wire42503371DILAWIRCXOn the marketTESSYS® Crown Reamer, blue, coarse42503371REAMREAFDOn the marketTESSYS® Crown Reamer, blue, fineB-04250337100263On the market