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EUDAMED last updated this device on Jun 9, 2026
60099003867SCDW5Sinapi Chest Drain is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by SINAPI Biomedical (Pty) Ltd. Placed on the EU market in Czechia. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06009900386720XL200S1 packaging level registered — each level carries its own UDI-DI.
06009900386720× 1 unitBase unit16009900386727× 15 units(01)06009900386720
European Medical Device Nomenclature — the EU product classification assigned to this device.
A060203PLEURAL DRAINAGES WITH VALVE AND KITS4 warnings recorded — scroll inside the panel to see all entries.
Single use only
1.Only appropriately trained personnel may use this device. 2. Compatibility of the Sinapi Chest Drain with thoracic catheters needs to be established by the user. 3. Assess the thoracic catheter connections for signs of an air leak. 4. Thoracic catheter dressings should be occlusive. 5. Ensure that there are no dependent loops or kinks in the patient drainage tube. 6. Little or no drainage may indicate a blockage in the drainage system. 7. Do not clamp tube, this will inhibit drain operation and may compromise respiratory function of patient.. 8. Samples of the drained fluid can be taken directly from the needle-free sampling port located on the front of the device. 9. When using suction control, keep device upright to prevent fluids entering suction regulator. 10. Discontinue use and replace with a new unit if body fluids entered the suction regulator. 11. Observing Universal Precautions, discard the SCD in a medical waste container, in accordance with the Waste Management policy of the health care facility. 12. 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 Czechia; available across 2 countries total.
| Country | On market since | Until |
|---|---|---|
| CzechiaPrimary placement | Mar 20, 2014 | 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.
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 →