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EUDAMED last updated this device on May 19, 2026
84356058UDI-DI-005WSTUART PS+VISCOSE BORPOL is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Deltalab, S.L.. Placed on the EU market in Poland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08435263896510300295.BO1 packaging level registered — each level carries its own UDI-DI.
08435263896510× 6 unitsBase unit08435263896541× 100 unitsES-MF-000000153(01)08435263896510
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
1 warning recorded — scroll inside the panel to see all entries.
1. If the unit packaging breaks, do not use the brush as it has no guarantee of sterility. 2. Do not use if any component is missing or if the printed product information is not displayed correctly. 3. Discard the product if you find any dirty, broken, and/ or splintered brushes and/or with the head not compacted and/or without it. 4. Do not use if the expiration date has been exceeded. 5. Do not use if alteration is observed in the means of transport. 6. Do not ingest the means of transport under any circumstances. 7. For single use only. Reuse of this product may cause infections. 8. Handle with care. Although unlikely, applying too much pressure force during use could break the brush. If broken, discard immediately. 9. Not suitable for any other application than its intended use. 10. For pediatric use it is recommended to use swabs with plastic or aluminium handle. 11. The use of the swab presents no difficulty for the intended end users. 12. The swabs with transport medium include instructions with diagrams for use on the primary package (peel-pouch). 13. After use, the swabs must be decontaminated of treated as contaminated medical waste. It is the responsibility of each laboratory to handle, treat and dispose the waste according to the regulations. Unused swabs can be considered non-hazardous products and can be disposed off accordingly.
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 1 country total.
| Country | On market since | Until |
|---|---|---|
| PolandPrimary placement | Mar 27, 2013 | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
A1102SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUMPrimary 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 →84356058UDI-DI-2268On the marketSTUART - Polystyrene + viscose84356058UDI-DI-005WOn the marketSTUART 13X165MM PS W/VISCOSE84356058UDI-DI-005WOn the marketSTUART SWAB ALUM+COTTON84356058UDI-DI-005WOn the marketSTUART SWAB WOOD+COTTON84356058UDI-DI-005WOn the marketSWAB 13X165MM PS W/POLYESTER84356058UDI-DI-005WOn the marketNo certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
2024 PR 0038IssuedNotified 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 →