EXTREMITER2020

Organization name

EMBITRON s.r.o.

SRN

CZ-MF-000041086

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.
• CW999

  Absolute contraindications: - acute conditions of venous thrombosis and embolism, suspected ; - aneurysm in the area of the treated limb (assessed as a risk of microembolisation from a local thrombus); - severe bleeding disorders and radial anticoagulant treatment; - acute open wounds with a serious risk of bleeding, risk of subcutaneous emphysema; - local purulent infections with a significant risk of spreading infectious agents and toxic tissue breakdown products, especially advanced necrosis (gangrene); - local malignant tumours, where the risk of spreading of tumour metastases could occur due to VCT; - limb oedema of cardiac, nephrogenic or hepatogenic origin; - Leiden mutation; - Pregnancy; - increased propensity for petechiae and haematomas at the site of the hermetic seal of the limb (oppression by the sealing cuff or the edge of the neck of the application cylinder); - psychiatric disorders not permitting closure of the limb in the applicator; - cardiac insufficiency associated with swelling; - septic conditions; - hyperthermia.
• CW011

  VCT is a medical method that is indicated and prescribed principally by a physician and administered by qualified and officially trained personnel - physiotherapist, a rehabilitation worker or nurse.

Primary placement in Czechia; available across 1 country total.

Trade name

not provided

UDI-DI code

08596526110009

Basic UDI-DI

B-08596526110009

Reference / catalog number

EXTREMITER2020

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The purpose of the EXTREMITER 2020 is to administer physical treatment procedures of vacuum-compression therapy (VCT) with the aim of positively influencing organic and functional disorders of blood circulation in the limbs.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Z120611VACUUM THERAPY EQUIPMENT

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