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EUDAMED last updated this device on Apr 23, 2024
803373771KIT0001D8THD SLIDE is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by THD S.P.A.. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
080337377108697100041 packaging level registered — each level carries its own UDI-DI.
08033737710869× 1 unitBase unit18033737710866× 50 units(01)08033737710869
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z12020604ULTRASONIC PROCTOSCOPES4 warnings recorded — scroll inside the panel to see all entries.
Primary placement in Italy; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | Mar 16, 2015 | Apr 23, 2024 |
IT-MF-000029427The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
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.No certificate specifically references this device's Basic UDI-DI.
803373771DIAS0001HAOn the marketTHD SELF BANDY803373771BAN000237On the marketTHD SensyProbe AX803373771ANOACC0001GMOn the marketTHD SOFTWARE803373771PROSW002BCOn the marketTHD SPHINKEEPER DELIVERY SYSTEMB-08033737711736On the marketTHD SPHINKEEPER SELF EXPANDABLE IMPLANTB-08033737711743On the market