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Organization name
UDI-DI code
Reference / catalog number

VXSY-10-1-PL — Class IIa MDR by OPED GmbH

MD Atlas
OPED GmbH

EUDAMED last updated this device on May 19, 2026

VXSY-10-1-PL

4046618Z120607VX8H

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: OPED GmbH
UDI-DI code: 04046618014660
Reference / catalog number: VXSY-10-1-PL

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Manufacturer information

Organization name: OPED GmbH
SRN: DE-MF-000008286
Manufacturer status: Active

Critical warnings

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

CW135
EUDAMED did not publish a description for this code.
CW014
EUDAMED did not publish a description for this code.
CW259
EUDAMED did not publish a description for this code.
CW999
The VADOplex System can optionally contain NiMH battery packs. Don’t try to open the device! The batteries may only be replaced by authorized specialists.
CW999
The use of this device requires the recommendation of the attending physician regarding the indication and the recommended duration of use
CW999
Absolute contraindications: • In patients where increased backflow to the heart could have a negative effect, e.g patients with decompensated heart failure or severe, non-adjustable hypertension • Acute thrombophlebitis • Acute deep leg vein thrombosis • Full-blown compartment syndrome (with necrosis of the musculature) Relative contraindications for the following cases - after weighing-up of the benefits and risks by the treating physician: • Pulmonary embolism • Severe infection of the treated extremity
CW999
Do not use the VADOplex System as a toy.
CW999
If the power cord or device case is obviously damaged, do not connect it to an AC power source as electrical shock could occur.
CW999
Do not drop the device, impact, or immerse in water. Don’t try to open the device!
CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 2 countries total.

Country	On market since	Until
GermanyPrimary placement	Jan 1, 2021	Still on market
Poland	Apr 26, 2024	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04046618014660
Basic UDI-DI: 4046618Z120607VX8H
Reference / catalog number: VXSY-10-1-PL
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z120607PNEUMATIC COMPRESSION EQUIPMENT

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

ORTH-02-14046618Z1206OTC7On the market ORTH-20-14046618Z120625OT7QOn the market VADOplex Foot Pad4046618M030405VXPADSEEOn the market VADOplex Foot Pad4046618M030405VXPADSEEOn the market VADOplex Foot Pad4046618M030405VXPADSEEOn the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.