BF MEDİKAL SANAYİ İTHALAT İHRACAT
TİCARET LTD.ŞTİ.

Located at
Feridun Çelik Mah. 1048. Cad. No:139/B Altındağ Ankara/Turkey
06360

has been found to comply with
ISO13485:2016

For the following scope:
DESIGN, PRODUCTION, ASSEMBLY, PACKAGING AND MARKETING OF MEDICAL DEVICES FOR STERILIZATION CONTROL,
MONITORING AND PACKAGING of STERILIZATION PACKAGING PRODUCTS: FLAT, GUSSETED AND TYVEK REELS; CREPE AND
SMS WRAPPING PAPERS, CHEMICAL INDICATORS: STEAM (TYPE 4, TYPE 5, TYPE 6, TYPE 5 INTEGRATOR), ETHYLENE OXIDE,
PLASMA, DRY HEAT AND FORMALDEHYDE CHEMICAL INDICATORS, PROCESS CHALLENGE DEVICES AND TEST PACKS: BOWIE
DICK TEST PACKS AND SHEETS, HELIX AND PCD TEST SYSTEMS, INDICATOR HOLDERS, STERILIZATION TAPES AND LABELS:
STEAM, ETHYLENE OXIDE AND PLASMA AUTOCLAVE TAPES (WITH AND WITHOUT INDICATOR); STEAM, ETHYLENE OXIDE,
PLASMA AND FORMALDEHYDE DOCUMENTATION LABELS AND LABEL GUN, STERILIZATION CONTAINER ACCESSORIES:
CONTAINER SECURITY LOCKS AND CONTAINER LABELS, WASHING AND CLEANING PROCESS MONITORS: WASHING MACHINE
INDICATORS, ULTRASONIC WASHING INDICATORS, PROTEIN RESIDUE TESTS AND INDICATOR HOLDERS, BIOLOGICAL
INDICATORS AND EQUIPMENT: STEAM, ETHYLENE OXIDE, DRY HEAT, FORMALDEHYDE AND PLASMA BIOLOGICAL
INDICATORS; INCUBATORS FOR BIOLOGICAL INDICATORS, CLEANING AND MAINTENANCE PRODUCTS: SURGICAL
INSTRUMENT RUST REMOVER AND AUTOCLAVE CLEANING SPRAY.

Certificate Issuance: 27.08.2025                      1st Surveillance: 27.08.2026
Certificate Expiry:     27.08.2028                     2nd Surveillance: 27.08.2027

Certificate No: QAMD20220745