Organization name

Sunmedic AB

SRN

SE-MF-000012997

Manufacturer status

Active

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

• CW999

  VivereX(+)™ system is contraindicated for: 1. Wounds with malignancy except in palliative care 2. Wounds with untreated osteomyelitis 3. Wounds with untreated non-enteric fistula 4. Wounds covered by necrotic tissue5. Wounds with exposed bone, blood vessels, nerves, organs or anastomotic site 6. Tracheostomy and surgical drains 7. Wounds in patients with known allergies to silicone, nylon or acrylic glue 8. For aspiration or suction purpose beyond those specified in the indications for use

Primary placement in Sweden; available across 19 countries total.

Trade name

VivereX+™ NPWT pump

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.

17350127834003

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.

B-17350127834003

Reference / catalog number

PDI600400

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

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

A single-use, portable negative-pressure wound therapy (NPWT) device intended to apply controlled suction to support the healing of acute and chronic wounds, including surgical incisions, grafts, burns, ulcers, and traumatic wounds with low to moderate exudate levels. The system typically consists of an electrically powered vacuum pump used in combination with an absorbent wound dressing, acting as exudate collection medium, and connection tubing. The device delivers continuous or intermittent negative pressure to the wound site to promote exudate management, support blood and interstitial fluid circulation, assist approximation of wound edges, promote granulation tissue formation, and prepare the wound bed for closure.

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.

• Z12019003WOUND TREATMENT EQUIPMENT

• Class IIa medical devices in EUDAMED

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