Organization name

Devroye Instruments SRL

SRN

BE-MF-000034423

Manufacturer status

Active

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

• Do not re-use
• Do not use if package is damaged

Primary placement in Belgium; available across 17 countries total.

Trade name

WAW Hybrid Tornado Punch 0.85

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.

05430003362129

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.

5430003362HybridTornadoY3

Reference / catalog number

0.852508

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

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

Status

On the market

Quantity

1

Additional product description

The WAW Hybrid Tornado Punch is a single use medical device intended to prepare follicular units for extraction from a patient's body, as part of a hair transplantation procedure. This is done by coring the tissues included in the hair follicle to separate them from the surrounding tissues. The movement of the WAW Hybrid Tornado Punch is intended to be provided by its accessory, the WAW Duo FUE System active device.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 0.85 MU50

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

European Medical Device Nomenclature — the EU product classification assigned to this device.

• V901699SPECIALIST SURGICAL INSTRUMENTS AND KITS NOT INCLUDED IN OTHER CLASSES, SINGLE-USE - OTHER

• Class IIa medical devices in EUDAMED

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