Organization name

Devroye Instruments SRL

SRN

BE-MF-000034423

Manufacturer status

Active

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

• Any manipulation of the medical device must be done only after a complete reading of this user manual. The device may only be operated and used by qualified personnel. The device is only intended for the specific use described in this manual. Any unauthorized modification of the medical device is prohibited and will void the manufacturer’s liability. No loss of essential performance due to EMC interference is to be expected with this device. Portable RF communications, including antennas, can affect medical electrical devices. These must not be used closer than 30 cm (12 inches) to any part of the medical device, including cables specified by the manufacturer. The motor blocks supplied with the system must never be sterilized, opened, soaked in alcohol or clean with compressed air. The device should only be used in a dedicated location such as private specialist centers and clinics, hospitals, doctors’ offices. This device has been tested according to the immunity test levels described in EN60601-1-2 for professional environment. For emission CISPR11 Group 1 class A was selected. Pictograms and warning signs on the devices must not be removed! If these signs are removed, the liability of Devroye Instruments is void. Use of this device adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this device and the other equipment sould be observed to verify that they are operating normally. This device must be used with accessories compatible with WAW Duo FUE System. Failure of the device/any part of the device caused by the use of a non-compatible accessory will void the warranty of the complete WAW Duo FUE System.

  OTHER

• The following profiles are contraindicated: Patients with soft cranial tissues. Patients with alopecia areata. Patients with frontal fibrosis alopecia.

  OTHER

Primary placement in Belgium; available across 18 countries total.

Trade name

WAW Software

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.

05430003362280

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.

54300033620WDFSystem69

Reference / catalog number

WAW Software V1

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 I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

The WAW Software, responsible for defining the parameters of functioning (rotation and oscillation movement) of the handpieces and mode (manual, semi-auto, auto or continuous) of the pedal (the Samsung tablet is supplied).

Additional information URL

https://devroyeinstruments.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.

• L0318INSTRUMENTS FOR SUPPORT OF SURGICAL DEVICES, REUSABLE

• Class I medical devices in EUDAMED

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