Surgify Halo

Organization name

Surgify Medical Oy

SRN

FI-MF-000017137

Manufacturer status

Active

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

• CW009

  EUDAMED did not publish a description for this code.
• CW001

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

  Limit the maximum speed of the motor
• CW999

  Device usage shall not exceed a total of 5 minutes.
• CW999

  Do not apply excessive force to the device or operative surface.
• CW999

  Do not intentionally touch soft tissue with the device.
• CW999

  Use the device in combination with sufficient irrigation.
• CW999

  Use the device with compatible motors and handpieces.
• CW999

  Use eye protection and a surgical mask while using the device.
• CW999

  Do not touch harder than bone objects, e.g., suction tubes or implants.

Primary placement in Finland; available across 13 countries total.

Trade name

Surgify Halo

UDI-DI code

06429811532243

Basic UDI-DI

64298301169SurgifyHaloSE

Reference / catalog number

40.125.NVG.H1

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 4 MU50

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

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

Certificate health across this manufacturer's portfolio.