의료기기 Class I Device 리스팅이력

최근 당사가 진행하여 등록시킨 Class I Device 제품 코드 목록입니다. 가장 핵심적인 제품들에 대해서만 리스트 되었습니다. 이 리스트는 총 프로젝트 진행 수는 아니며 동일 제품 코드를 10건 이상 진행한 케이스들도 있습니다.

Product Code Device Common Name Product Code Device Common Name
DZA Dental Intraoral Drill IFB Cytocentrifuge
EAZ Dental Operation Light IOL, IOG Treadmill, Powered, Mechanical
EBH Impression Tray, Resin Material IQI, IPX, IPY, IQK Orthosis, Limb/Rib/Lumbo-sacral/Cervical
ECG Orthodontic Braket Aligner ISA, LYG Therapeutic Massager
EFW, JEQ, MMD Toothbrush, Manual/Powered, Ionic ITG Bandage, Cast
EGD Dental Intraoral Wax KIY Slide Culture Chamber
EHB X-ray Collimator KPA Automated Slide Stainer
EIF Dental Retractor Accessories KZF Medical Examination Device
FGY Injection Cannula LDZ Alcohol Containing Fixative
FNJ, INY Bed MCF Ultraviolet Sanitation Sterilization
GDF Surgical Needle NAC Hyrophilic Wound dressing
GFE Dermabrasion Brush NDP Dental Implant Accessories
GKH Automated blood cell diluting Apparatus OFO Airway Suction Kit
HTD Forceps PWA Breast Pump Accessory

의료기기 510K - Class II Device 허가이력

최근 당사가 진행하여 510(k) 허가를 받아낸 제품 코드 목록입니다. 이 리스트는 총 프로젝트 진행 수는 아니며 동일 제품 코드를 10건 이상 진행한 케이스들도 있습니다.

Product Code Device Common Name Product Code Device Common Name
DZE, NHA Dental Implant System JEY Dental Bone Plate
DZL Dental Fixation Screw KGN Collagen Wound Dressing
DQA Oximeter KLE Resin Tooth Bonding Agent
EBF Tooth Shade Resin Material KWP Spinal interlaminal fixation orthosis
EHD Extraoral X-ray System KWQ Spinal intervertebral body fixation orthosis
EMA Dental Cement LYC Dental Bone Grafting Material
FBK Endoscopic injection needle, Gastroenterology-urology MAX Spinal Intervertebral body fusion device
FCG Biopsy Needle MNH, MNI Spinal Pedicle screw system
FDI Flexible Snare NEW Surgical Suture
GCJ Laparoscope NXC Orthodontic Aligner
GEX Medical Laser System ODP Intervertebral fusion device with bone graft, cervical
HRS, HWC Bone Fixation Plate and Screw ONF Powered Light Based Non-laser Surgical instrument with Thermal Effect
ILY Infrared Lamp OTJ Laparoscopic Single Port Access Device