Warszawa ,March 19, 2024

To whom it may concern

BALTON S.P Z.o.o is a company which manufactures sterile, disposable medical devices for dialysis and
haemodialysis , radiology , cardiology , urology anaesthesiology and general surgery . Our products are
manufactured with high manufacturing and quality standards, we already have in the international market for
about years where they are used by institutions, clinics, hospitals around the world.

At the request of our dealer MEDICAL PERUVIAN SERVICES E.I.R.L, we are sending New free sale certificate
for the registration of Polymer guide wire with hydrophilic coating product . Headquarter office Address is located
in ul Nowy Świat 7/14 00-496 Warszawa, Poland and Our manufacturing site is ul Modlińska 294 03-152
Warszawa,Poland where manufacturer this kind of product. Only one of the two addresses can be expressed in
the free sale certificate
We sent the free sale certificate again according to our standards because we could not send it before because
our company Balton SP Zoo was in audit between December 20, 2023 until February 20, 2024 . In the other
hands we send documents as : sterilization inform, biocompatibility reports,essential requirements,Risk
management inform, protocols.

Our Polymer guide wire with hydrophilic coating products are the following as detailed below:
Nomenclature used: UMDNS UMDNS Code:11925 Guide wires Trade mark : ENTER CLASS: IIA
NAME OF PRODUCT REF GENERAL PRESENTATION
PPN14150H
PPN14180H
PPN14200H
PPN14260H
PPN1850H
PPN1880H
PPN18120H
PPN18150H
PPN18180H
PPN18200H
PPN18260H
PPN2550H
PPN2580H
PPN25120H
PPN25150H
PPN25180H
PPN25200H
PPN25260H
PPN3250H
Polymer guide wire with PPN3280H Cardboard box containing:1,3,5,10 low density polyethylene bag
Hydrophilic coating PPN32120H with sterile medical grade Tyvek paper
PPN32150H Each bag contains :1 unit polymer guide wire with
PPN32180H Hydrophilic coating
PPN32200H
PPN32260H
PPN3550HF
PPN3580HF
PPN35120HF
PPN35150HF
PPN35180HF
PPN35200HF
PPN35260HF
PPN3850HF
PPN3880HF
PPN38120HF
PPN38150HF
PPN38180HF
PPN38200HF
PPN38260HF
PPN3850HM
PPN3880HM
PPN38120HM
PPN38150HM
PPN38180HM
NAME OF PRODUCT REF GENERAL PRESENTATION
PPN38200HM
PPN38260HM
PPN3550HM
PPN3580HM
PPN35120HM
PPN35150HM
PPN35180HM
PPN35200HM
PPN35260HM
PPN3550HS
PPN3580HS
PPN35120HS
PPN35150HS
PPN35180HS
PPN35200HS
PPN35260HS
PPN3850HS
PPN3880HS
PPN38120HS
PPN38150HS
PPN38180HS
PPN38200HS
PPN38260HS
PPNA14150H
PPNA14180H Cardboard box containing:1,3,5,10 low density polyethylene bag
Polymer guide wire with PPNA14200H with sterile medical grade Tyvek paper
Hydrophilic coating PPNA14260H Each bag contains :1 unit polymer guide wire with
PPNA1850H Hydrophilic coating
PPNA1880H
PPNA18120H
PPNA18150H
PPNA18180H
PPNA18200H
PPNA18260H
PPNA2550H
PPNA2580H
PPNA25120H
PPNA25150H
PPNA25180H
PPNA25200H
PPNA25260H
PPNA3250H
PPNA3280H
PPNA32120H
PPNA32150H
PPNA32180H
PPNA32200H
PPNA32260H
PPNA3550HF
PPNA3580HF
PPNA35120HF
PPNA35150HF
PPNA35180HF
PPNA35200HF
PPNA35260HF
PPNA3850HF
PPNA3880HF
PPNA38120HF
PPNA38150HF
PPNA38180HF
PPNA38200HF
PPNA38260HF
 NAME OF PRODUCT REF GENERAL PRESENTATION
PPNA3850HM
PPNA3880HM
PPNA38120HM
PPNA38150HM
PPNA38180HM
PPNA38200HM
PPNA38260HM
PPNA3550HM
PPNA3580HM
PPNA35120HM
PPNA35150HM Cardboard box containing:1,3,5,10 low density polyethylene bag
Polymer guide wire with PPNA35180HM with sterile medical grade Tyvek paper
Hydrophilic coating PPNA35200HM Each bag contains :1 unit polymer guide wire with
PPNA35260HM Hydrophilic coating
PPNA3550HS
PPNA3580HS
PPNA35120HS
PPNA35150HS
PPNA35180HS
PPNA35200HS
PPNA35260HS
PPNA3850HS
PPNA3880HS
PPNA38120HS
PPNA38150HS
PPNA38180HS
PPNA38200HS
PPNA38260HS

Balton Sp Z.o.o complies with send all documents request by our dealer in Peru MEDICAL PERUVIAN
SERVICES E.I.R.L in order to obtain the healthauthorization of our products in Peruvian land

Best regards

General Manager