Organization name

Deltalab, S.L.

SRN

ES-MF-000000153

Manufacturer status

Active

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

• CW010

  Not suitable for any other application than its intended use. Do not use if the packaging has any signs of breakage or damage. If you see that the unit package has lost its integrity, do not use the swab as there is no guarantee of its sterility. Do not use if you notice that the swab is dirty. Discard the product if you find any broken brushes, with edges or without a head. Do not use if the liquid of the transport swab with media is cloudy or seems altered. Only for single use, the reuse of this product may cause infections. Handle carefully. Any strong pressure during use, although unlikely, could break the swab. In the case of any damage, discard immediately. After use, the swabs must be decontaminated or treated as contaminated medical waste. It is the responsibility of each laboratory to handle, treat and dispose the waste according to the current legislation. Unused swabs can be considered non-hazardous products and can be disposed of accordingly. All the above is applicable to the enrichment media supplied with flocked swab. Do not use if the expiration date has been exceeded. Do not use if any component is missing or if the printed product information is not displayed correctly. Do not ingest the means of transport under any circumstances.

Primary placement in Spain; available across 7 countries total.

Trade name

VICUM 2ML FLOCKED SWAB NASOPH.80MM FLOW

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

08435605814950

Basic UDI-DI

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.

84356058UDI-DI-246C

Reference / catalog number

304234KF

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

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.

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

6

Additional product description

—

Additional information URL

https://www.deltalabgroup.com/eifus

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• A1102SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM

• Class IIa medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.

Certificate health across this manufacturer's portfolio.