UP2 Retrofitter Tube

Organization name

V-VEIL-UP PRODUCTION

SRN

RO-MF-000010676

Manufacturer status

Active

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

• CW009

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.

Primary placement in Romania; available across 1 country total.

Placed on the market in Romania; per-country availability dates not published.

Trade name

UP2 Retrofitter Tube

UDI-DI code

05944760090305

Basic UDI-DI

594476009UP2RTUBEHH

Reference / catalog number

80081171102

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

The UP2 Retrofitter™ tube is a container used for the collection, storage, preservation, transport and performance of laboratory analyses for in vitro diagnostic use of specimens. The product is intended for use by the professional or the patient to collect, store and transport secretions, various fluids and substances from the nose, ears, oral cavity, vaginal cavity, cervix and anus, for subsequent examination. Once closed, the UP2 Retrofitter™ tube no longer allows the collected sample to be touched, keeping the specimen between its walls and the tube.

Additional information URL

https://www.v-veil-up-production.com/

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.

• W02079099VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - OTHER
• W050299DEVICES FOR SAMPLES TRANSPORT - OTHER
• W050301020102SAMPLES ANALYSES, PLASTIC TUBES WITHOUT ADDITIVES
• W02079085VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - CONSUMABLES