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ZA-MF-000012126SINAPI Collection Container 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 Poland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Jun 9, 2026
60099003867SCCW3Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)06009888639306
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
3 warnings recorded — scroll inside the panel to see all entries.
1. This device is only intended for use by appropriately trained personnel. 2. Observing Universal Precautions, discard the collection container as medical waste in accordance with the Waste Management policy of the health care facility. 3. 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.
Single use only
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.
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.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in Poland; available across 15 countries total.
| Country | On market since | Until |
|---|---|---|
| PolandPrimary placement | — | Still on market |
| Austria | — | Still on market |
| Belgium | — | Still on market |
| Cyprus | — | Still on market |
| Germany | — | Still on market |
| EL | — | Still on market |
| Spain | — | Still on market |
| Croatia | — | Still on market |
| Hungary | — | Still on market |
| Ireland | — | Still on market |
| Italy | — | Still on market |
| Luxembourg | — | Still on market |
| Netherlands | — | Still on market |
| Portugal | — | Still on market |
| Slovenia | — | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
06009888639306Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
60099003867SCCW3D1150UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
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.
1 packaging level registered — each level carries its own UDI-DI.
06009888639306× 1 unitBase unit16009888639303× 30 unitsEuropean Medical Device Nomenclature — the EU product classification assigned to this device.
A0680DRAINAGE AND FLUID COLLECTION DEVICES - ACCESSORIESNo 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.
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