FLOCK ST 100 TUBE SELFSWAB VAGINAL

Organization name

Deltalab, S.L.

SRN

ES-MF-000000153

Manufacturer status

Active

Certificate health across this manufacturer's portfolio.

2 warnings recorded — scroll inside the panel to see all entries.

• CW275

  Use of the kit poses no difficulty for the intended user, provided that these instructions for correct sampling and storage until delivery to healthcare personnel are followed. You may also consult the explanatory video via the QR code on the labelling of the product packaging and in this document. If you have any questions about the procedure, consult the healthcare personnel. Inadequate sampling could give rise to false negative results.
• CW010

  - Do not use if some component is missing or if the printed information on the product is not clearly visible. - Unused swabs can be considered non-hazardous products and can be disposed of according to this criterion. - Do not perform vaginal self-sampling while you are menstruating. At least 4 days must have passed since your last bleeding before performing a self-sampling. - Do not perform self-sampling if you are pregnant or within three months of giving birth. - Do not use vaginal creams or douches for three days prior to self-examination. - Do not have sexual relations or gynecological examinations two days before self-sampling. Not suitable for any other than its intended use. - Do not use if there is evidence of damage to the packaging. - If the single-unit container is damaged, do not use the swab, since sterility is not guaranteed. Do not use if there is evidence of dirty or if the swab is broken, or present sharp edges or is missing the head. For single use only, reutilisation of this product can cause infections. - Handle the swab with care. Although unlikely, applying too much pressure during use could break the swab. Discard immediately, if broken. - Do not eat, drink, or smoke during sample collection. Once sample collection is complete, dispo- se of the remaining material according to current legislation.

Primary placement in Spain; available across 1 country total.

Trade name

FLOCK ST 100 TUBE SELFSWAB VAGINAL

UDI-DI code

08435605814882

Basic UDI-DI

84356058UDI-DI-3169

Reference / catalog number

200392.SV

Issuing entity

GS1

Risk category

IVDR Class A

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

6

Additional product description

The kit includes: - One standard flocked swab with a 100 mm break point, packaged in a sealed, non-deformable, round-bottom polypropylene tube. - One 12 ml EUROTUBO® round-bottom tube with a skirt, individually packaged. - The kit is presented in a peel-pack

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.

• W05019099SAMPLES COLLECTION DEVICES - OTHER