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EUDAMED last updated this device on May 29, 2026
60099003902UBTULEllavi UBT is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by SINAPI Biomedical (Pty) Ltd. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06009900390239UBT1 packaging level registered — each level carries its own UDI-DI.
06009900390239× 1 unitBase unit16009900390236× 25 unitsNot intended for the EU market(01)06009900390239
European Medical Device Nomenclature — the EU product classification assigned to this device.
U100102POSTPARTUM INTRAUTERINE CATHETERS5 warnings recorded — scroll inside the panel to see all entries.
Single use only
Precautions: 1. Excessive force should not be used when inserting the ELLAVI into the uterus. 2. Do not fill the balloon under force including the use of pressure bags or pumps. 3. The stop valve should stay open for the duration of treatment, unless the supply bag cannot be hung at the required height. Warnings: 1. This device is only intended for use by appropriately trained personnel. 2. If bleeding has not stopped or considerably decreased within 15 minutes after placement, surgical intervention or rapid referral, to a higher level of care, should be considered. 3. Maximum indwelling time of the balloon is 24 hours. 4. Any patient with a UBT in situ, should receive prophylactic broad spectrum antibiotics as determined by the attending clinician. 5. To avoid the potential risk of air embolism, the balloon should never be filled with air or any other gas. 6. Observing universal precautions, discard the UBT in a medical waste container, in accordance with the waste management policy of the health care facility. 7. NOTE: Any serious incident that occurs in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.
Primary placement in Spain; available across 3 countries total.
| Country | On market since | Until |
|---|---|---|
| SpainPrimary placement | Apr 11, 2024 | Still on market |
| Hungary | — | Still on market |
| Poland | — | Still on market |
ZA-MF-000012126The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
OTHER
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.
Certificate health across this manufacturer's portfolio.
ES23/00000108SupplementedNotified 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 →