Quanta System S.p.A.

• Reusable 5x Optical Fiber Ref OFJ008012

  Class IIa EUDAMED Active

• Litho 60 Ref PVMS00049

  Class IIb EUDAMEDFDA UDI Active

• Reusable 5x Optical Fiber Performance Ref OAF402712

  Class IIa EUDAMEDFDA UDI Active

• Reusable 10x Optical Fiber Ref MF800RST

  Class IIa EUDAMED Active

• Pulvis 60+ Ref PFMS00006

  Class IIb EUDAMED Active

• Light C Ref PCMS00309

  Class IIb EUDAMED Active

• DenaVe Ref PDMS00256

  Class IIb EUDAMED Active

• Single Use Optical Fiber Ref OAF003691

  Class IIa EUDAMEDFDA UDI Active

• Single Use Optical Fiber Performance Ref MFP272ST

  Class IIa EUDAMED Active

• Suprema VT Ref PCMS00501

  Class IIb EUDAMEDFDA UDI Active

• Reusable 10x Optical Fiber Ref OAF702793

  Class IIa EUDAMEDFDA UDI Active

• Reusable 10x Optical Fiber Ref OAF009903

  Class IIa EUDAMEDFDA UDI Active

• Reusable 10x Optical Fiber Ref UL272R

  Class IIa EUDAMEDFDA UDI Active

• Single Use Optical Fiber Ref OAF009991

  Class IIa EUDAMED Active

• Single Use Optical Fiber Gastro Ref OAF102711

  Class IIa EUDAMEDFDA UDI Active

• Reusable 10x Optical Fiber Ref OAF702713

  Class IIa EUDAMEDFDA UDI Active

• Reusable 5x Optical Fiber Ref FSV550

  Class IIa EUDAMEDFDA UDI Active

• Suprema VT+ Ref PCMS00503

  Class IIb EUDAMEDFDA UDI Active

• Single Use Optical Fiber Ball-Tip Ref OAF302711

  Class IIa EUDAMEDFDA UDI Active

• 585 Ref PDMS00580

  Class IIb EUDAMEDFDA UDI Active

• Litho 100 Ref PVMS00055

  Class IIb EUDAMEDFDA UDI Active

• Single Use Optical Fiber Lateral Ref OFJ506011

  Class IIa EUDAMED Active

• Youlaser PRIME Ref PYMS00012

  Class IIb EUDAMEDFDA UDI Active

• Reusable 5x Optical Fiber Ref FSV000

  Class IIa EUDAMEDFDA UDI Active

• Reusable 10x Optical Fiber Ref OAF006093

  Class IIa EUDAMEDFDA UDI Active

• Cyber Ho 150 Ref PVMS00060

  Class IIb EUDAMED Active

• Surgical Laser Fiber Ref EMP-FBX200HR

  Class IIa EUDAMEDFDA UDI Active

• LaserClast Tm Fiber Ref FT-248

  Class IIb EUDAMEDFDA UDI Active

• Cyber Ho 100 Ref PVMS00050

  Class IIb EUDAMED Active

• Reusable 10x Optical Fiber Performance Ref OAF402703

  Class IIa EUDAMED Active

• Reusable 5x Optical Fiber Ref OFJ009912

  Class IIa EUDAMED Active

• Reusable 10x Optical Fiber Ref UL550R

  Class IIa EUDAMEDFDA UDI Active

• Nanostar R Ref PCMS00344

  Class IIb EUDAMED Active

• Reusable 5x Optical Fiber Ref OAF702712

  Class IIa EUDAMEDFDA UDI Active

• Single Use Optical Fiber Ref OFJ001511

  Class IIa EUDAMEDFDA UDI Active

• Sirius Ref MS01

  Class IIb EUDAMED Active

• Single Use Optical Fiber Ref UL200S

  Class IIa EUDAMEDFDA UDI Active

• Reusable 10x Optical Fiber Performance Ref OAF402003

  Class IIa EUDAMED Active

• Single Use Optical Fiber Ref OFJ002011

  Class IIa EUDAMEDFDA UDI Active

• Single Use Optical Fiber Ref UL365S

  Class IIa EUDAMEDFDA UDI Active

• Single Use Optical Fiber Ref UL999S

  Class IIa EUDAMEDFDA UDI Active

• Reusable 10x Optical Fiber Ref FSX000

  Class IIa EUDAMEDFDA UDI Active

• Surgical Laser Fiber Ref EMP-FBX550HR

  Class IIa EUDAMEDFDA UDI Active

• Single Use Optical Fiber Ref FSI550

  Class IIa EUDAMEDFDA UDI Active

• Single Use Optical Fiber Performance Ref OAF402701

  Class IIa EUDAMED Active

• Reusable 10x Optical Fiber Ref OAF003603

  Class IIa EUDAMEDFDA UDI Active

• Single Use Optical Fiber Ref OAF005511

  Class IIa EUDAMEDFDA UDI Active

• Suprema 4V Ref PCMS00504

  Class IIb EUDAMEDFDA UDI Active

• Reusable 10x Optical Fiber Ref OAF002713

  Class IIa EUDAMEDFDA UDI Active

• Q-PLUS Star 2 Ref PCMS00306

  Class IIb EUDAMED 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