Qvintip

Organization name

Aprovix AB

SRN

SE-MF-000048905

Manufacturer status

Active

Primary placement in Sweden; available across 1 country total.

Trade name

Qvintip

UDI-DI code

07350187090039

Basic UDI-DI

73501870910-012EG

Reference / catalog number

10-012

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

1

Additional product description

Non-sterile, single-use vaginal self-sampling kit for collection of vaginal fluid for in vitro diagnostic analysis of high-risk HPV and other sexually transmitted infections (STIs). The kit consists of a plastic vaginal sampler with detachable tip and a co-packed labelled sample collection container enabling secure sample transfer and traceability. The detachable tip is removed after sampling and placed into the container for transport to a laboratory for analysis. Intended for self-collection; not reusable. MDR Class A medical device, traceable via UDI-DI and lot/batch number. Manufactured in Sweden under ISO 13485:2016.

Additional information URL

No additional information URL provided by the manufacturer.

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.

• A1101SAMPLE COLLECTION NEUTRAL SWABS