Quanta System S.p.A.

• Reusable 10x Optical Fiber Performance Ref OFC402013

  Class IIa EUDAMED Active

• Single Use Optical Fiber Ref OFC702711

  Class IIa EUDAMED Active

• Single Use Optical Fiber Ref OAF703601

  Class IIa EUDAMEDFDA UDI Active

• Single Use Optical Fiber Ball-Tip Ref OFJ302711

  Class IIa EUDAMEDFDA UDI Active

• Single Use Optical Fiber Ref OAF002091

  Class IIa EUDAMEDFDA UDI Active

• Single Use Optical Fiber Ref OFC703611

  Class IIa EUDAMED Active

• Light A Ref PAMS00031

  Class IIb EUDAMED Active

• Single Use Optical Fiber Ref FSI272

  Class IIa EUDAMEDFDA UDI Active

• Single Use Optical Fiber Ball-Tip Ref OFC302711

  Class IIa EUDAMEDFDA UDI Active

• Fiber Dust Ref PFMS00005

  Class IIb EUDAMEDFDA UDI Active

• Reusable 10x Optical Fiber Ref OFC009913

  Class IIa EUDAMED Active

• Surgical Laser Fiber Ref EMP-FBX200HS

  Class IIa EUDAMEDFDA UDI Active

• Single Use Optical Fiber Lateral Ref OAF506011

  Class IIa EUDAMEDFDA UDI Active

• Domino Suprema Ref PCMS00507

  Class IIb EUDAMEDFDA UDI Active

• Single Use Optical Fiber Ref OAF702701

  Class IIa EUDAMEDFDA UDI Active

• Light B Ref PCMS00308

  Class IIb EUDAMED Active

• Reusable 10x Optical Fiber Ref UL800R

  Class IIa EUDAMEDFDA UDI Active

• Single Use Optical Fiber Ref OAF003611

  Class IIa EUDAMEDFDA UDI Active

• Reusable 10x Optical Fiber Ref OAF002703

  Class IIa EUDAMEDFDA UDI Active

• Reusable 5x Optical Fiber Ref OAF005512

  Class IIa EUDAMEDFDA UDI Active

• Laser Surgery Device Tower 70W Ref PVMS00066

  Class IIb EUDAMED Active

• Light C Ref PCMS00340

  Class IIb EUDAMED Active

• Litho Ref PVMS00033

  Class IIb EUDAMED Active

• Reusable 10x Optical Fiber Performance Ref MFP272RST

  Class IIa EUDAMED Active

• Single Use Optical Fiber Ref OAF703611

  Class IIa EUDAMEDFDA UDI Active

• Youlaser CO2 Ref PGMS00010

  Class IIb EUDAMED Active

• Single Use Optical Fiber Ref OAF006011

  Class IIa EUDAMEDFDA UDI Active

• Single Use Optical Fiber Ref OAF002001

  Class IIa EUDAMEDFDA UDI Active

• Reusable 10x Optical Fiber Ref OFC008013

  Class IIa EUDAMED Active

• Youlaser PRIME CO2 Ref PGMS00017

  Class IIb EUDAMEDFDA UDI Active

• MultiLASE TFL Ref UL600

  Class IIb EUDAMEDFDA UDI Active

• Reusable 10x Optical Fiber Performance Ref OAF402013

  Class IIa EUDAMEDFDA UDI Active

• Single Use Optical Fiber Performance Ref OAF402791

  Class IIa EUDAMED Active

• Surgical Laser Fiber Ref EMP-FBX200BHS

  Class IIa EUDAMEDFDA UDI Active

• Reusable 10x Optical Fiber Ref OFC702713

  Class IIa EUDAMED Active

• Domino Ref PAMS00030

  Class IIb EUDAMED Active

• Chrome Ref PNMS00189

  Class IIb EUDAMEDFDA UDI Active

• Reusable 5x Optical Fiber Ref OAF703612

  Class IIa EUDAMEDFDA UDI Active

• Reusable 10x Optical Fiber Ref OAF003693

  Class IIa EUDAMEDFDA UDI Active

• Reusable 10x Optical Fiber Performance Ref OAF402713

  Class IIa EUDAMEDFDA UDI Active

• Youlaser CO2 Ref PGMS00011

  Class IIb EUDAMED Active

• Laser Surgery Device Tower 30W Ref PVMS00065

  Class IIb EUDAMED Active

• Single Use Optical Fiber Lateral Ref FLI600

  Class IIa EUDAMEDFDA UDI Active

• Studio Ref PNMC00014

  Class IIb EUDAMED Active

• Venacure 1470 Pro Ref H787VC1470PRO

  Class IIb EUDAMEDFDA UDI Active

• Fiber Dust PRO Ref PFMS00009

  Class IIb EUDAMEDFDA UDI Active

• Reusable 10x Optical Fiber Ref FSX365

  Class IIa EUDAMEDFDA UDI Active

• Reusable 5x Optical Fiber Ref FSV200

  Class IIa EUDAMEDFDA UDI Active

• Light A Star Ref PCMS00301

  Class IIb EUDAMED Active

• Single Use Optical Fiber Ball-Tip Ref UL272B

  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