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Organization name
UDI-DI code
Reference / catalog number

AMIES SWAB PS+VISCOSE BORPOL — Class IIa MDR by Deltalab, S.L.

MD Atlas
Deltalab, S.L.

EUDAMED last updated this device on May 19, 2026

AMIES SWAB PS+VISCOSE BORPOL

84356058UDI-DI-005W

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Deltalab, S.L.
UDI-DI code: 08435263896503
Reference / catalog number: 300287.BO

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Manufacturer information

Organization name: Deltalab, S.L.
SRN: ES-MF-000000153
Manufacturer status: Active

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Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
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.

Market distribution

Primary placement in Poland; available across 1 country total.

Country	On market since	Until
PolandPrimary placement	Oct 13, 2011	Still on market

Device identification

Trade name: AMIES SWAB PS+VISCOSE BORPOL
UDI-DI code: 08435263896503
Basic UDI-DI: 84356058UDI-DI-005W
Reference / catalog number: 300287.BO
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 6
Additional product description: —
Additional information URL: https://www.deltalabgroup.com/eifus
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

A1102SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Certificates

Certificate health across this manufacturer's portfolio.

2024 PR 0038Issued
Quality assuranceNotified body: 0318Expiry: Oct 21, 2029