Quanta System S.p.A.

• Duetto Suprema Ref PCMS00502

  Class IIb EUDAMEDFDA UDI Active

• Single Use Optical Fiber Ref UL800S

  Class IIa EUDAMEDFDA UDI Active

• Single Use Optical Fiber Performance Ref OAF402011

  Class IIa EUDAMEDFDA UDI Active

• Reusable 10x Optical Fiber Ref OAF005513

  Class IIa EUDAMEDFDA UDI Active

• Reusable 10x Optical Fiber Ref OAF005503

  Class IIa EUDAMEDFDA UDI Active

• Single Use Optical Fiber Ref OFA001511

  Class IIa EUDAMEDFDA UDI Active

• Thunder Ref PCMS00400

  Class IIb EUDAMED Active

• Reusable 10x Optical Fiber Ref OAF008013

  Class IIa EUDAMEDFDA UDI Active

• Q-Plus A Ref PCMS00303

  Class IIb EUDAMED Active

• Reusable 10x Optical Fiber Ref OAF702703

  Class IIa EUDAMEDFDA UDI Active

• Reusable 10x Optical Fiber Performance Ref OAF402793

  Class IIa EUDAMED Active

• Reusable 10x Optical Fiber Ref OAF703603

  Class IIa EUDAMEDFDA UDI Active

• Duetto MT Ref PCMS00300

  Class IIb EUDAMED Active

• Single Use Optical Fiber Ref MS150ST

  Class IIa EUDAMED Active

• Accure Ref PFMS00012

  Class IIb EUDAMED Active

• Litho EVO Ref PVMS00058

  Class IIb EUDAMEDFDA UDI Active

• Litho 150 Ref PVMS00062

  Class IIb EUDAMEDFDA UDI Active

• Single Use Optical Fiber Ref OFJ005511

  Class IIa EUDAMED Active

• Laserclast35 Ref FT-246

  Class IIb EUDAMEDFDA UDI Active

• Reusable 10x Optical Fiber Ref OAF008003

  Class IIa EUDAMEDFDA UDI Active

• Single Use Optical Fiber Lateral Ref OAF506001

  Class IIa EUDAMEDFDA UDI Active

• Single Use Optical Fiber Ref OAF008011

  Class IIa EUDAMEDFDA UDI Active

• Reusable 10x Optical Fiber Ref FSX272

  Class IIa EUDAMEDFDA UDI Active

• Reusable 10x Optical Fiber Ref FSX550

  Class IIa EUDAMEDFDA UDI Active

• Single Use Optical Fiber Ref OAF009901

  Class IIa EUDAMEDFDA UDI Active

• Reusable 5x Optical Fiber Ref OAF009912

  Class IIa EUDAMEDFDA UDI Active

• Single Use Optical Fiber Ref FSI150

  Class IIa EUDAMEDFDA UDI Active

• Single Use Optical Fiber Ref OAF008001

  Class IIa EUDAMEDFDA UDI Active

• Surgical Laser Fiber Ref EMP-FBX272HS

  Class IIa EUDAMEDFDA UDI Active

• Reusable 10x Optical Fiber Performance Ref OAF402093

  Class IIa EUDAMED Active

• Reusable 10x Optical Fiber Ref OAF002013

  Class IIa EUDAMEDFDA UDI Active

• Single Use Optical Fiber Ref OAF703691

  Class IIa EUDAMEDFDA UDI Active

• Ultralight Ref PCMS00307

  Class IIb EUDAMED Active

• Single Use Optical Fiber Ref FSI200

  Class IIa EUDAMEDFDA UDI Active

• Reusable 10x Optical Fiber Ref OAF009913

  Class IIa EUDAMEDFDA UDI Active

• Reusable 10x Optical Fiber Ref UL365R

  Class IIa EUDAMEDFDA UDI Active

• Single Use Optical Fiber Ball-Tip Ref OAF302721

  Class IIa EUDAMEDFDA UDI Active

• Reusable 10x Optical Fiber Ref OFJ008013

  Class IIa EUDAMED Active

• Surgical Laser Fiber Ref EMP-FBX365HR

  Class IIa EUDAMEDFDA UDI Active

• Reusable 10x Optical Fiber Ref OAF703613

  Class IIa EUDAMEDFDA UDI Active

• Q-Plus C Ref PCMS00332

  Class IIb EUDAMED Active

• Nanostar Y Ref PCMS00343

  Class IIb EUDAMED Active

• Single Use Optical Fiber Ref MF200ST

  Class IIa EUDAMEDFDA UDI Active

• Single Use Optical Fiber Ref OAF002011

  Class IIa EUDAMEDFDA UDI Active

• Reusable 10x Optical Fiber Ref FSX200

  Class IIa EUDAMEDFDA UDI Active

• Single Use Optical Fiber Ref UL550S

  Class IIa EUDAMEDFDA UDI Active

EUDAMED SRN

IT-MF-000007393

EU VAT number

IT-10647810158

EUDAMED status

Active

EUDAMED registered name

Quanta System S.p.A.

EUDAMED abbreviated name

Quanta System

Registered address

109, via Acquedotto, 21017, Samarate, Italy

Email

[email protected]

Phone

+390331376797

PRRC contact

Dario Bandiera(public in EUDAMED)

2 certificates·2 valid, 0 expired·MDR 2·next expiry 13 Dec 2026

• 2021

  • 27 Apr 2021 Z-1842-2021 Class II Terminated Product sterility is potentially compromised. Distribution: Nationwide distribution via 6 US distributors Submission number: K180158
  • 27 Apr 2021 Z-1843-2021 Class II Terminated Product sterility is potentially compromised. Distribution: Nationwide distribution via 6 US distributors Submission number: K131473
  • 27 Apr 2021 Z-1844-2021 Class II Terminated Product sterility is potentially compromised. Distribution: Nationwide distribution via 6 US distributors Submission number: K160513

• 2012

  • 7 Nov 2012 Z-0691-2013 Class II Terminated Quanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional materials for products distributed in the U.S. which did not specify that some of the claims made therein were not meant to apply to the U.S. distributed devices. Distribution: Class II Recall - Worldwide Distribution - USA including TX, AZ, OR, and CO. Only US product is affected by this recall. Submission numbers: K073549, K123168
  • 7 Nov 2012 Z-0692-2013 Class II Terminated Quanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional materials for products distributed in the U.S. which did not specify that some of the claims made therein were not meant to apply to the U.S. distributed devices. Distribution: Class II Recall - Worldwide Distribution - USA including TX, AZ, OR, and CO. Only US product is affected by this recall. Submission number: K051113
  • 7 Nov 2012 Z-0693-2013 Class II Terminated Quanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional materials for products distributed in the U.S. which did not specify that some of the claims made therein were not meant to apply to the U.S. distributed devices. Distribution: Class II Recall - Worldwide Distribution - USA including TX, AZ, OR, and CO. Only US product is affected by this recall. Submission numbers: K070805, K083207