Quanta System S.p.A.

• Litho Ref PVMS00039

  Class IIb EUDAMED Active

• Reusable 10x Optical Fiber Ref MF365RST

  Class IIa EUDAMED Active

• Single Use Optical Fiber Ref MF365ST

  Class IIa EUDAMED Active

• Chrome Ref PNMS00190

  Class IIb EUDAMEDFDA UDI Active

• Litho DK 30 Ref PVMS00025

  Class IIb EUDAMEDFDA UDI Active

• Single Use Optical Fiber Ref OAF702711

  Class IIa EUDAMEDFDA UDI Active

• Single Use Optical Fiber Ref MF550ST

  Class IIa EUDAMED Active

• Surgical Laser Fiber Ref EMP-FBX272HR-C

  Class IIa EUDAMEDFDA UDI Active

• Youlaser MT Ref PYMS00006

  Class IIb EUDAMED Active

• Reusable 10x Optical Fiber Ref MF550RST

  Class IIa EUDAMED Active

• Surgical Laser Fiber Ref EMP-FBX1000HS

  Class IIa EUDAMEDFDA UDI Active

• Reusable 10x Optical Fiber Ref MF272RST

  Class IIa EUDAMED Active

• Multidiode Derma 1470 Ref PDMS00203

  Class IIb EUDAMEDFDA UDI Active

• Single Use Optical Fiber Ref OAF006091

  Class IIa EUDAMEDFDA UDI Active

• Single Use Optical Fiber Ref OFJ702711

  Class IIa EUDAMEDFDA UDI Active

• Single Use Optical Fiber Performance Ref OAF402711

  Class IIa EUDAMEDFDA UDI Active

• Single Use CO2 Laser Fiber Ref HAF005001

  Class IIa EUDAMED Active

• Reusable 10x Optical Fiber Gastro Ref OAF103693

  Class IIa EUDAMEDFDA UDI Active

• Reusable 10x Optical Fiber Performance Ref MFP200RST

  Class IIa EUDAMED Active

• Single Use Optical Fiber Ref OFC005511

  Class IIa EUDAMED Active

• Q-Plus R Ref PCMS00304

  Class IIb EUDAMED Active

• Asset Ref PNMS00174

  Class IIb EUDAMED Active

• Thunder HR Ref PCMS00403

  Class IIb EUDAMED Active

• MH01 Ref MH01

  Class IIb EUDAMED Active

• Reusable 5x Optical Fiber Ref OFJ702712

  Class IIa EUDAMED Active

• Reusable 10x Optical Fiber Ref OAF006013

  Class IIa EUDAMEDFDA UDI Active

• Reusable 10x Optical Fiber Ref OAF002793

  Class IIa EUDAMEDFDA UDI Active

• Single Use Optical Fiber Ref OFC009911

  Class IIa EUDAMED Active

• Surgical Laser Fiber Ref EMP-FBX200BHS-C

  Class IIa EUDAMEDFDA UDI Active

• Light 4V Ref PCMS00310

  Class IIb EUDAMED Active

• Reusable 10x Optical Fiber Ref UL999R

  Class IIa EUDAMEDFDA UDI Active

• Cyber TM 150 Ref PUMS00012

  Class IIb EUDAMED Active

• Reusable 5x Optical Fiber Ref FSV800

  Class IIa EUDAMEDFDA UDI Active

• Single Use Optical Fiber Ball-Tip Ref FBI272

  Class IIa EUDAMEDFDA UDI Active

• Single Use Optical Fiber Performance Ref MFP200ST

  Class IIa EUDAMED Active

• Single Use Optical Fiber Ref UL150S

  Class IIa EUDAMEDFDA UDI Active

• Reusable 5x Optical Fiber Ref MS272RST

  Class IIa EUDAMED Active

• Reusable 5x Optical Fiber Ref FSV365

  Class IIa EUDAMEDFDA UDI Active

• Surgical Laser Fiber Ref EMP-FBX1000HR

  Class IIa EUDAMEDFDA UDI Active

• Reusable 10x Optical Fiber Ref OAF003613

  Class IIa EUDAMEDFDA UDI Active

• Single Use Optical Fiber Ref OFJ009911

  Class IIa EUDAMED Active

• Coloplast TFL Drive Ref TFLD01

  Class IIb EUDAMEDFDA UDI Active

• Reusable 10x Optical Fiber Ref UL200R

  Class IIa EUDAMEDFDA UDI Active

• Single Use Optical Fiber Ref MF800ST

  Class IIa EUDAMED Active

• Single Use Optical Fiber Ref FSI800

  Class IIa EUDAMEDFDA UDI Active

• Reusable 10x Optical Fiber Ref OAF006003

  Class IIa EUDAMEDFDA UDI Active

• Single Use Optical Fiber Ref OAF702791

  Class IIa EUDAMEDFDA UDI Active

• Reusable 10x Optical Fiber Ref OAF009993

  Class IIa EUDAMED Active

• Discovery Pico Derm Ref PCMS00338

  Class IIb EUDAMED Active

• Reusable 5x Optical Fiber Ref MS365RST

  Class IIa 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