- Role
- Country
- Date of registration
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EUDAMED last updated this device on May 27, 2026
081768802SmokeEvacSensDMPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →UNIVERSAL BLUE™ is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by I.C. Medical, Inc.. Placed on the EU market in Portugal. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
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 →00817688020363Basic 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 →081768802SmokeEvacSensDMICM-000-0599UDI 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 →(01)00817688020363
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z12019004SURGICAL SMOKE EVACUATION SYSTEMSSterile
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 →No certificate specifically references this device's Basic UDI-DI.
Primary placement in Portugal; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| PortugalPrimary placement | Mar 10, 2023 | Still on market |
US-MF-000022350No 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.081768802SmokeAccessS55On the marketSpeculum Tubing081768802SmokeAccessNS6JOn the marketSpeculum Tubing081768802SmokeAccessS55On the marketICM-000-0447081768802SmokeEvacSensDMOn the marketICM-000-0276081768802SmokeEvacFiltrGGOn the marketICM-000-0262081768802SmokeEvacFiltrGGOn the market