Certifications

 

ISO 13485 / MDD

PERIMED est certifié en accord avec la norme ISO 13485 :2003 et est conforme avec les exigences en MDD.

Certificate no 15887:
Certifies the Perimed quality management system.
ISO 13485:2003
(replaces SS-EN ISO 9001:1994 and EN 46001:1997)

Certificate no 41310877:
Certifies the Perimed quality assurance system is in conformity of the requirements in the council directive 14 June in 1993.
93/42/EEC, MDD Annex II

Certificate no 41314303:
Certifies the Perimed quality assurance system is in conformity of the requirements in the council directive 14 June in 1993.
93/42/EEC, MDD Annex V

 

FDA Compliance Information

The following products have received Premarket Clearance - 510(k) - from FDA in the United States of America.

 

PeriFlux System 5000

510(k) numbers: K974285, K932068, K990960 and K011899.

PeriFlux PF 5001 Main Unit

PeriFlux PF 5010 LDPM Unit (Laser Doppler Perfusion Monitor)

PeriFlux PF 5020 Temperature Unit

PeriFlux PF 5040 tcpO₂/CO₂ Unit

PeriFlux PF 5050 Pressure Unit

PeriFlux System 4000

510(k) numbers: K922368 and K932068.

PeriFlux PF 4001 Master

PeriFlux PF 4002 Satellite

PeriFlux PF 4005 Tissue Heater

PeriFlux PF 3

(Product discontinued)

PeriScan PIM 3 System

PeriScan PIM II System

510(k) numbers for PeriScan Systems: K920844.

 

SONDES

510(k) numbers: K974285, K932068, K935495 and K922368.

PROBE 401 (301) Angled Probe

PROBE 402 (302) Needle Probe

PROBE 403 (303) Angled Probe

PROBE 404 (304) Suturable Angled Probe

PROBE 405 (305) Angled Probe

PROBE 407 (307) Small Probe with Miniholders

PROBE 408 (308) Standard Probe

PROBE 410 (310) Angled Stainless Steel Probe

PROBE 411 (311) Needle Probe for Micromanipulator

PROBE 412 (312) Deep Measurement Probe

PROBE 413 (313) Integrating Probe

PROBE 414 (314) Angled Small Probe

PROBE 416 (316) Dental Probe

PROBE 418 (318) Master Probe

PROBE 455 (355) Angled Thermostatic Laser Doppler Probe

PROBE 457 (357) Small Angled Thermostatic Laser Doppler Probe