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EUDAMED last updated this device on Mar 7, 2026
B-06223004251078ULTRAMED ENDOTRACHEAL TUBE ORAL/NASAL CUFFED Size 4 is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E). Placed on the EU market in Bulgaria. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
062230042510784006-4(01)06223004251078
European Medical Device Nomenclature — the EU product classification assigned to this device.
R01030201ENDOTRACHEAL TUBES, CUFFED, NOT REINFORCED6 warnings recorded — scroll inside the panel to see all entries.
Single use only. Sterile if package is unopened or undamaged. Storage at room temperature (Upper limit of temperature= 30℃ ± 2 ℃). Storage up to Humidity (RH= 65% ± 5). Do not use this device in the Magnetic Resonance (MR) environment (MR Unsafe)
Prior to intubation, deflate the cuff completely. After intubation, inflate the cuff using the minimum volume of air required to provide an effective seal. Immediately after cuff inflation, auscultate both lung fields. If breath sounds diminished over one lung field or absent over one or both fields, adjust the tube as required. Endotracheal tube placement should be confirmed by viewing the position of the tube tip with a chest radiograph. It’s recommended to be used by skilled and trained personnel.
EG-MF-0000385621421C05201201No 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.Do not use after the expiry date
Primary placement in Bulgaria; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| BulgariaPrimary placement | Jan 1, 2020 | Dec 31, 2029 |
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 certificate specifically references this device's Basic UDI-DI.
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